Abstract
Background
Respiratory tract infections are common among Umrah pilgrims due to crowding, close interpersonal contact, shared accommodation, and prolonged exposure to respiratory pathogens. Gargling has been proposed as a simple non-pharmaceutical respiratory hygiene intervention, but evidence on its feasibility, adherence, and acceptability during pilgrimage remains limited.
Methods
A mixed-methods, quasi-experimental pilot-controlled study was conducted among 90 Malaysian Umrah pilgrims from two travel batches, allocated by batch to an intervention group (n=46) or control group (n=44). The intervention group received mouthwash and was instructed to gargle with 20 mL twice daily. Quantitative outcomes included self-reported respiratory symptoms, coughing frequency, impact on Umrah activities, and adherence. Open-ended responses explored perceived benefits, facilitators, barriers, and user experiences.
Results
Most participants were female (65.6%) and aged 40–59 years. Cough and sore throat were the most commonly reported symptoms in both groups. No statistically significant differences were observed between groups for individual respiratory symptoms, number of symptoms, coughing frequency, or impact on Umrah activities (all p > 0.05). The intervention group showed non-significant trends towards lower prevalence of runny nose and less disruption of activities. Among respondents, 68.2% reported gargling twice daily almost every day. However, only 22/46 intervention participants completed the post-pilgrimage adherence assessment, representing 52.2% loss to follow-up. Participants generally perceived gargling as beneficial for respiratory and oral health, while forgetfulness and busy schedules were the main barriers.
Conclusion
Significant reductions in respiratory symptoms were not observed, but antiseptic gargling was acceptable, feasible, and generally well received. Larger multicentre studies incorporating objective microbiological outcomes and adherence-enhancing strategies are warranted.
Keywords: Gargling, Mass gathering health, Mixed methods, Respiratory Tract Infection, Umrah, Feasibility Study
الملخص
الخلفية
تُعد التهابات الجهاز التنفسي من المشكلات الصحية الشائعة بين المعتمرين نتيجة الازدحام، والتواصل المباشر، والسكن المشترك، والتعرض لمجموعة متنوعة من مسببات الأمراض التنفسية. وقد طُرحت الغرغرة بوصفها تدخلاً بسيطاً وغير دوائي لتعزيز النظافة التنفسية، إلا أن الأدلة المتعلقة بإمكانية تطبيقها عملياً، والالتزام بها، ومدى تقبلها في بيئة العمرة الفعلية لا تزال محدودة.
طرق البحث
أُجريت دراسة تجريبية شبه تجريبية مختلطة المنهج على 90 معتمراً ماليزياً من مجموعتين منفصلتين للسفر. وُزّع المشاركون بحسب مجموعة السفر، وليس بالتوزيع العشوائي الفردي، إلى مجموعة تدخل (46 مشاركاً) ومجموعة ضابطة (44 مشاركاً). تلقى أفراد مجموعة التدخل غسول فم مطهراً يحتوي على كلوريد السيتيل بيريدينيوم (CPC) والثيمول، وطُلب منهم الغرغرة بـ20 مل مرتين يومياً خلال فترة إقامتهم في مكة المكرمة والمدينة المنورة. وشملت المخرجات الكمية الأعراض التنفسية المبلغ عنها ذاتياً، وعدد الأعراض، وتكرار السعال، وتأثير الأعراض على أداء مناسك العمرة، ومدى الالتزام بالغرغرة. كما جرى تحليل الإجابات المفتوحة موضوعياً لاستكشاف الفوائد المتصورة والعوامل المحفزة والمعوقات وتجارب المشاركين.
النتائج
كان نحو ثلثي المشاركين من الإناث، وكان 60.0% منهم في الفئة العمرية 40–59 عاماً، بمتوسط عمر بلغ 44.6 ± 9.96 سنة. وكان السعال والتهاب الحلق أكثر الأعراض شيوعاً في المجموعتين. ولم تُلاحظ فروق ذات دلالة إحصائية بين مجموعتي التدخل والضبط في الأعراض التنفسية الفردية، أو عدد الأعراض، أو تكرار السعال، أو تأثير الأعراض على أنشطة العمرة. فعلى سبيل المثال، أبلغ 37.0% من مجموعة التدخل عن سيلان الأنف مقابل 56.8% في المجموعة الضابطة، إلا أن هذا الاختلاف لم يصل إلى الدلالة الإحصائية.
أكمل 22 فقط من أصل 46 مشاركاً في مجموعة التدخل استبيان الالتزام بعد العودة من العمرة، أي بمعدل استجابة 47.8% وفقد متابعة بلغ 52.2%. ومن بين المستجيبين، أفاد 68.2% بأنهم كانوا يتغرغرون مرتين يومياً في معظم الأيام، و18.2% مرة واحدة يومياً في معظم الأيام. ولذلك، ينبغي عدم اعتبار نسبة 68.2% معدل التزام لجميع أفراد مجموعة التدخل بسبب ارتفاع نسبة الفقد في المتابعة واحتمال تحيز عدم الاستجابة.
أظهر التحليل النوعي خمسة محاور رئيسية؛ إذ رأى المشاركون أن الغرغرة مفيدة لصحة الجهاز التنفسي والفم، وأسهم الوعي الصحي والرغبة في الوقاية من المرض وبعض الدوافع الدينية المرتبطة بالنظافة في تشجيع استخدامها. وفي المقابل، كان النسيان وضيق الوقت وكثافة جدول العمرة من أهم العوائق أمام الالتزام المنتظم. كما أشار المشاركون إلى أن الأعراض التنفسية أثرت سلباً في الراحة والتركيز والقدرة البدنية أثناء أداء العبادات.
الاستنتاج
لم تُظهر الغرغرة المطهرة انخفاضاً ذا دلالة إحصائية في الأعراض التنفسية مقارنة بالمجموعة الضابطة، إلا أنها بدت مقبولة وقابلة للتطبيق بشكل عام بين المعتمرين الماليزيين. وتدعم النتائج إجراء دراسات مستقبلية متعددة المراكز وبأحجام عينات أكبر، مع استخدام مؤشرات ميكروبيولوجية موضوعية، ومقاييس معتمدة للأعراض، ووسائل أكثر موثوقية لقياس وتعزيز الالتزام. وينبغي تفسير النتائج باعتبارها نتائج أولية لدراسة جدوى، وليس دليلاً على الفعالية السريرية للغرغرة.
الكلمات المفتاحية: العمرة, التهابات الجهاز التنفسي, الغرغرة, كلوريد السيتيل بيريدينيوم, صحة التجمعات البشرية, دراسة الجدوى, المنهج المختلط
Introduction
Umrah is a religious pilgrimage that attracts millions of Muslims annually to Saudi Arabia. Similar to Hajj, Umrah involves large gatherings, crowding, close interpersonal contact, and shared accommodation, which may all facilitate the transmission of respiratory pathogens. Respiratory tract infections are among the most common health problems experienced by pilgrims, and they are an important cause of morbidity during Hajj and Umrah.1 They may also affect the physical comfort of pilgrims and their ability to perform religious activities.
Respiratory tract infections among Hajj and Umrah pilgrims are associated with a broad range of viral and bacterial pathogens. Rhinoviruses and influenza viruses are among the most frequently detected viral agents, and Streptococcus pneumoniae and Haemophilus influenzae are important bacterial pathogens identified in pilgrimage settings. A recent systematic review of studies conducted during the 2012–2025 Hajj seasons confirmed influenza viruses and rhinoviruses as the predominant respiratory viruses, and S. pneumoniae and H. influenzae were among the commonly reported bacterial pathogens.2 Recent molecular studies have further demonstrated the substantial circulation of respiratory pathogens among pilgrims. Among 207 infected Hajj pilgrims, human rhinovirus was detected in 40.6%, Staphylococcus aureus in 35.8%, and H. influenzae in 30.4%, with viral–bacterial co-detection in 28.5%.3 In a 2022 survey of Egyptian pilgrims returning from Hajj and Umrah, influenza was detected in 1.4% of Hajj pilgrims and 1.1% of Umrah pilgrims, and SARS-CoV-2 was detected in 9.9% and 6.7%, respectively.4 These findings indicate that although the prevalence and spectrum of respiratory pathogens vary among pilgrim populations and seasons, the circulation of respiratory pathogens remains substantial, where influenza viruses and rhinoviruses are consistently identified as important causes of infection.
Vaccination, hand hygiene, face mask use, and coughing etiquette remain important preventive measures, but respiratory symptoms continue to be frequently reported during mass gatherings.5, 6, 7 In addition, the use of antibiotics to treat viral respiratory symptoms may contribute to the inappropriate consumption of antibiotics and antimicrobial resistance. Therefore, simple, low-cost, and acceptable non-pharmaceutical interventions may complement the existing preventive strategies among pilgrims. Gargling with antiseptic mouthwash has been proposed as an oral and respiratory hygiene measure because agents such as cetylpyridinium chloride can reduce the microbial burden in the oral and oropharyngeal cavity.8 Previous studies have shown the potential benefits of gargling with water, saline, and antiseptic for reducing upper respiratory tract infections or the viral load, although the findings remain inconsistent among populations and settings.9, 10, 11, 12 Evidence remains limited regarding the real-world use of antiseptic gargling among Umrah pilgrims, particularly regarding adherence, acceptability, and user experience.
The success of any preventive intervention depends on its biological effectiveness but also on whether it is practical, acceptable, and sustainable for users. This is especially important during pilgrimages where participants experience physically demanding schedules, environmental challenges, and competing priorities. Therefore, the aims of the present study were to evaluate respiratory symptoms, adherence, and user experiences with respect to an antiseptic gargling intervention among Malaysian Umrah pilgrims by using a mixed-methods pilot approach.
Materials and Methods
Study design and participants
A mixed-methods, quasi-experimental, pilot-controlled study was conducted among Malaysian Umrah pilgrims recruited from two separate travel batches organized by Amani Travel. The study employed a mixed-methods approach by combining quantitative assessments of respiratory symptoms and adherence with qualitative explorations of participant experiences, perceptions, and barriers related to gargling practices. This study was designed primarily to assess feasibility, acceptability, and adherence rather than to provide a definite estimate of clinical efficacy.
Participants were allocated to intervention and control groups according to their pre-existing travel batch, without individual randomization. Batch allocation was used to facilitate intervention delivery, minimize contamination between participants travelling together, and maintain the operational structure of the organized Umrah groups. The intervention group received an antiseptic gargling intervention during Umrah, whereas the control group received standard infection prevention education and continued their usual practices. In total, 90 participants were enrolled, with 46 participants in the intervention group and 44 participants in the control group. For this pilot study, recruitment was pragmatic and based on eligible consenting pilgrims in the two participating batches rather than a formal efficacy-based sample size calculation.
Sample size rationale: formal hypothesis-driven sample size calculation was not performed as this was a pilot feasibility study. The number of participants was determined pragmatically by the eligible consenting pilgrims available in the two participating travel batches during the study period. This is consistent with guidance for pilot and feasibility studies, where the rationale for participant numbers is based primarily on feasibility objectives rather than statistical power for definitive efficacy testing.13 Therefore, the final sample of 90 participants (46 in the intervention group and 44 in the control group) was intended to provide preliminary information on recruitment, retention, adherence, acceptability, and implementation, and to inform the design and formal sample-size calculation of a future adequately powered trial.
Inclusion and exclusion criteria
Eligible participants were Malaysian Umrah pilgrims aged 18 years or over who travelled directly from Malaysia to Makkah and Almadinah Almunawwarah, and who were willing to comply with the study procedures, including symptom recording and follow-up assessments.
Participants were excluded if they were unable to perform gargling due to medical or physical limitations, had pre-existing respiratory tract infection symptoms at the time of enrolment, or had a history of hypersensitivity or allergic reactions to antiseptic mouthwash ingredients if allocated to the intervention group.
Before enrolment, eligible pilgrims were provided with information about the study objectives, procedures, voluntary nature of participation, and confidentiality of their responses, and informed consent was obtained before data collection.
The consent process was completed before enrolment and the collection of any data. Potential participants were informed about the study's purpose, procedures, expected participation, confidentiality, voluntary nature of participation, and their right to decline or withdraw without consequence. They were given the opportunity to ask questions, and only participants who provided informed consent were enrolled in the study.
Intervention
Participants in the intervention group attended an educational session for 30 min on respiratory tract infection prevention and the potential benefits of antiseptic gargling during Umrah. They were provided with Watsons Cool Mint Mouthwash (Watsons Personal Care Stores Sdn. Bhd.), which is a commercially available alcohol-free antiseptic mouthwash that contains cetylpyridinium chloride and thymol as active antimicrobial ingredients.
Participants were instructed to gargle with 20 mL of the mouthwash twice daily throughout their stay in Makkah and Almadinah Almunawwarah. Verbal instructions were provided before departure, and daily WhatsApp reminders were sent to encourage adherence to the gargling regimen and symptom monitoring.
The mouthwash was selected pragmatically as an alcohol-free, commercially available formulation containing cetylpyridinium chloride and thymol. The ready availability and relatively low cost of the mouthwash were considered relevant to evaluating the feasibility of a scalable self-administered intervention in a pilgrimage setting.
Participants in the control group attended an educational session on infection prevention during Umrah but were not provided with mouthwash or specific instructions regarding gargling.
Follow-up and data collection
Participants completed a questionnaire developed by the investigators covering demographic characteristics and respiratory symptoms experienced during Umrah. Symptoms assessed included cough, sore throat, phlegm, runny nose, blocked nose, fever, and breathing difficulty. The instrument consisted predominantly of factual, single-item categorical questions and open-ended items rather than a multi-item psychometric scale; therefore, internal consistency statistics such as Cronbach's alpha were not considered applicable. Items were reviewed by the research team for relevance and clarity before use. Open-ended responses could be provided in Malay and were translated into English for analysis and reporting as described in the following.
The Umrah program lasted 12 days. Between Day 10 and Day 12, participants in both groups completed an online questionnaire to record respiratory symptoms experienced during Umrah. The survey link was distributed through the WhatsApp communication channel used for study reminders. This timing allowed sufficient exposure to the pilgrimage environment and to the gargling regimen before assessment for the intervention group. Intervention participants also reported their compliance with gargling and any challenges. Participation in the surveys was voluntary.
Two weeks after returning to Malaysia, participants from the intervention group completed a post-pilgrimage online questionnaire to assess preventive practices, the occurrence and severity of respiratory symptoms, and perceived impacts of symptoms on Umrah activities. Participants were asked about perceived benefits, barriers, and experiences related to gargling. Open-ended responses were collected to explore factors that influenced adherence, perceived usefulness, and the acceptability of gargling practices.
Outcome measures
The quantitative outcomes were self-reported respiratory tract infection symptoms, number of symptoms, frequency of coughing, perceived impact of symptoms on Umrah activities, and adherence to gargling among participants in the intervention group.
The qualitative outcomes included perceived benefits of gargling, factors encouraging gargling, barriers to adherence, support for continued practice, and perceived effects of respiratory symptoms on worship activities.
Statistical analysis
Quantitative data were analyzed using descriptive and comparative statistics. Categorical variables were represented as frequencies and percentages, and compared between groups using Pearson's chi-square test, or Fisher's exact test if the expected cell counts were small. Age was summarized descriptively using the mean and standard deviation. Formal normality testing was not required for the primary inferential analyses because the study outcomes subjected to between-group testing were categorical rather than continuous. A two-sided p-value <0.05 was considered to indicate a statistically significant difference. Given the pilot nature of the study, analyses were exploratory and adjustment for multiple comparisons was not applied.
Qualitative analysis
Qualitative responses from open-ended questions were explored using thematic analysis. Responses were reviewed repeatedly, coded, and grouped into recurring themes related to perceived benefits, facilitators, barriers, and participant experiences. Responses originally provided in Malay were translated into English by the research team for reporting purposes while also preserving their contextual meaning. In the following, illustrative quotes are presented in English, with selected original Malay wording retained where relevant.
Results
Demographic characteristics
In total, 90 participants were enrolled in the study and allocated to the intervention group (n = 46) and control group (n = 44). All participants were of Malay ethnicity. The majority of participants (60.0%) were aged between 40 and 59 years, with a mean age of 44.6 years (standard deviation = 9.96 years). Approximately two-thirds of the participants were female. There were no statistically significant differences in the age or sex distributions between the intervention and control groups.
Respiratory symptoms among participants
Cough and sore throat were the most commonly reported symptoms in both groups (Table 1). In the intervention group, 25 participants (54.3%) reported coughs and 25 (54.3%) reported sore throats compared with 27 (61.4%) and 26 (59.1%) in the control group, respectively. Runny nose was reported by 17 participants (37.0%) in the intervention group and 25 participants (56.8%) in the control group. Other symptoms included phlegm, blocked nose, fever, and breathing difficulty. None of the between-group differences in individual symptoms were statistically significant (all p > 0.05; Table 1).
Table 1.
Self-reported symptoms of respiratory tract infection among participants in the intervention and control groups (n = 90).
| Symptoms | Intervention group (n = 46), n (%) | Control group (n = 44), n (%) | p-value |
|---|---|---|---|
| Cough | 25 (54.3) | 27 (61.4) | 0.501 |
| Phlegm | 18 (39.1) | 18 (40.9) | 0.863 |
| Sore throat | 25 (54.3) | 26 (59.1) | 0.650 |
| Runny nose | 17 (37.0) | 25 (56.8) | 0.059 |
| Blocked nose | 18 (39.1) | 19 (43.2) | 0.696 |
| Fever | 11 (23.9) | 9 (20.5) | 0.693 |
| Breathing difficulty | 4 (8.7) | 7 (15.9) | 0.296 |
Number of symptoms reported
The numbers of respiratory tract infection symptoms reported by participants in the intervention and control groups are shown in Table 2. In the intervention group, 11 participants (23.9%) were asymptomatic, 19 (41.3%) reported one to three symptoms, and 16 (34.8%) reported four or more symptoms. In the control group, six participants (13.6%) were asymptomatic, 20 (45.5%) reported one to three symptoms, and 18 (40.9%) reported four or more symptoms. There was no statistically significant difference in the number of symptoms reported in the intervention and control groups (p = 0.456).
Table 2.
Number of respiratory tract infection symptoms among participants in the intervention and control groups (n = 90).
| Group | Asymptomatic n (%) | 1 to 3 symptoms n (%) | 4 or more symptoms n (%) | p-value |
|---|---|---|---|---|
| Intervention | 11 (23.9) | 19 (41.3) | 16 (34.8) | 0.456 |
| Control | 6 (13.6) | 20 (45.5) | 18 (40.9) |
Frequency of coughing
Among symptomatic participants who reported coughing (n = 58), the frequency of coughing was similar between the intervention and control groups (Table 3). In the intervention group, 12 participants (48.0%) reported occasional coughing, four (16.0%) reported frequent coughing, and nine (36.0%) reported persistent coughing. In the control group, 13 participants (48.1%) reported occasional coughing, five (18.5%) reported frequent coughing, and nine (33.3%) reported persistent coughing. There was no statistically significant difference in the frequency of coughing between the two groups (p = 0.964).
Table 3.
Frequency of coughing among symptomatic participants (n = 58).
| Group | Occasional n (%) | Frequent n (%) | Persistent n (%) | p-value |
|---|---|---|---|---|
| Intervention | 12 (48.0) | 4 (16.0) | 9 (36.0) | 0.964 |
| Control | 13 (48.1) | 5 (18.5) | 9 (33.3) |
Impacts of symptoms on umrah activities
Table 4 shows the level of agreement regarding whether Umrah activities were affected by symptoms among symptomatic participants (n = 73). In the intervention group, 22 participants (62.9%) disagreed that their Umrah activities were affected, six (17.1%) were unsure, and seven (20.0%) agreed that their activities were affected. In the control group, 22 participants (57.9%) disagreed, four (10.5%) were unsure, and 12 participants (31.6%) agreed that their activities were affected. There was no statistically significant difference regarding whether Umrah activities were affected in the intervention and control groups (p = 0.456).
Table 4.
Level of agreement that Umrah activities were affected by symptoms among symptomatic participants (n = 73).
| Group | Disagree n (%) | Unsure n (%) | Agree n (%) | p-value |
|---|---|---|---|---|
| Intervention | 22 (62.9) | 6 (17.1) | 7 (20.0) | 0.456 |
| Control | 22 (57.9) | 4 (10.5) | 12 (31.6) |
Frequency of gargling
Among the 46 participants allocated to the intervention group, 22 completed the post-pilgrimage adherence questionnaire and were included in the adherence analysis, with a response rate of 47.8% and loss to follow-up of 52.2%. Among the respondents, 15 (68.2%) reported gargling twice daily almost every day, four (18.2%) once daily almost every day, two (9.1%) every other day, and one (4.5%) a few times a week (Table 5). Adherence was available only for the respondents, so these percentages should not be interpreted as adherence rates for the full intervention group.
Table 5.
Frequency of gargling among intervention participants who completed the adherence assessment (n = 22).
| Frequency | n (%) |
|---|---|
| Rarely | 0 (0.0) |
| A few times a week | 1 (4.5) |
| Every other day | 2 (9.1) |
| Once a day, almost every day | 4 (18.2) |
| Twice a day, almost every day | 15 (68.2) |
Qualitative findings
Qualitative analysis identified five recurring themes related to the implementation of gargling during Umrah.
Theme 1: gargling was perceived as beneficial for respiratory and oral health
Many participants perceived gargling as useful for maintaining respiratory and oral health during Umrah, and believed that it could reduce throat infection, coughing, or respiratory discomfort in crowded settings. These statements represent the participants' subjective perceptions and should not be interpreted as evidence of clinical efficacy because the quantitative comparisons did not indicate statistically significant reductions in respiratory outcomes.
"Ya, ada membantu." ("Yes, it helped.")
"Ya, bagi mengelakkan jangkitan tekak." ("Yes, to prevent throat infections.")
"Ya, mengurangkan jangkitan berkaitan dengan saluran pernafasan." ("Yes, it helped reduce respiratory-related infections.")
"Patut diteruskan bagi mencegah batuk dan kebersihan." ("It should be continued to prevent coughing and maintain hygiene.")
"Patut diamalkan untuk memastikan kebersihan mulut." ("It should be practiced to maintain oral cleanliness.")
Theme 2: factors encouraging gargling practices
Several factors encouraged participants to practice gargling consistently, including health awareness, the desire to prevent illness, adherence to recommendations provided by the study team, and religious beliefs related to personal hygiene. Some participants viewed gargling as a proactive health behavior that could help prevent illness during pilgrimage.
Representative quotes included:
"Pencegahan lebih baik daripada merawat." ("Prevention is better than cure.")
"Mengikut saranan." ("I followed the recommendation given.")
"Bersiwak dan berkumur sunnah Baginda SAW." ("Using siwak and gargling are practices encouraged in the Sunnah.")
Theme 3: forgetfulness and busy schedules were barriers to gargling
Despite generally positive perceptions, participants identified forgetfulness and competing priorities during Umrah activities as the main barriers to regular gargling. Several participants acknowledged that gargling had not yet become part of their established daily routine.
Representative quotes included:
"Selalu lupa untuk berkumur." ("I often forgot to gargle.")
"Terlupa dan tidak sempat." ("I forgot and sometimes did not have enough time.")
"Belum menjadi rutin kebiasaan." ("It has not yet become part of my regular routine.")
"Sesekali sahaja kerana jadual sangat padat." ("I only did it occasionally because my schedule was very busy.")
Theme 4: support for continued gargling during and after Umrah
Most participants expressed support for continuing gargling practices beyond the study period. Many believed that gargling should be routinely practiced during Umrah and other forms of travel as a simple measure to protect against respiratory illness.
Representative quotes included:
"Sangat digalakkan untuk berkumur secara rutin semasa mengerjakan umrah kerana sangat membantu mengurangkan risiko jangkitan pernafasan." ("Routine gargling during Umrah is highly encouraged because it helps reduce the risk of respiratory infections.")
"Boleh juga diamalkan setiap kali travel keluar negara." ("It can also be practiced whenever travelling overseas.")
"Ya. Dapat mencegah bila berkumur daily." ("Yes, daily gargling may help prevent illness.")
Theme 5: respiratory symptoms negatively affected worship experience
Participants reported that respiratory symptoms reduced their comfort, concentration, and physical stamina during worship activities. Some described difficulties maintaining focus during prayer and completing religious activities comfortably.
Representative quotes included:
"Menjadi tidak selesa sepanjang beribadah." ("I experienced discomfort throughout my worship activities.")
"Ketika solat wujud ketidakselesaan." ("The symptoms caused discomfort during prayer.")
"Kepala pening dan hidung tersumbat membuat kurang khusyuk dan tidak cukup stamina untuk beribadah." ("Dizziness and nasal congestion affected my concentration and reduced my stamina for worship.")
Discussion
This mixed-methods pilot study evaluated the feasibility, adherence, and user experiences for an antiseptic gargling intervention among Malaysian Umrah pilgrims. Statistically significant differences were not observed between the intervention and control groups in terms of individual respiratory symptoms (all p > 0.05), number of symptoms (p = 0.456), coughing frequency (p = 0.964), or impacts on Umrah activities (p = 0.456). Accordingly, this study should be interpreted as an exploratory feasibility study rather than as evidence of clinical effectiveness.
Respiratory symptoms were common among participants, where cough and sore throat were the most frequently reported symptoms. Similarly, previous studies demonstrated that respiratory tract infections were among the most common health problems experienced during Hajj and Umrah. A survey of 783 pilgrims in France showed that more than 80% had respiratory symptoms and almost 50% took antibiotics during their pilgrimage.14 An earlier study amongst Malaysian pilgrims found an even higher prevalence of respiratory tract infections (93.4%), where 78.2% met the criteria for influenza-like illness.7 Pneumonia and other severe respiratory infections are important causes of healthcare use among pilgrims, particularly among older adults and those with comorbidities, and bacterial and viral pathogens such as S. pneumoniae, H. influenzae, and influenza viruses have been reported in pilgrimage settings.15 Recent molecular surveillance supports this continuing burden, where recent studies reported detecting rhinovirus in 40.6% of ill Hajj pilgrims, influenza in approximately 9–12% of Egyptian Hajj/Umrah returnees, and at least one respiratory virus in 38.5% of symptomatic returning Iranian pilgrims.3,4 These data reinforce the relevance of evaluating simple, scalable respiratory hygiene interventions in pilgrimage settings.
The differences found in the present study were not significant but potentially favorable patterns were observed in the intervention group, including a lower prevalence of runny nose (37.0% vs 56.8%; p = 0.059) and fewer participants reporting disruption of Umrah activities due to respiratory symptoms (20.0% vs 31.6%; p = 0.456). Given the exploratory nature of this pilot study and limited sample size, these findings should not be interpreted as evidence of clinical efficacy, but instead they provide encouraging preliminary signals that warrant further evaluation in a larger, adequately powered study.
The lack of significant findings should also be interpreted in the context of previous evidence regarding gargling. A randomized trial in Japan found that participants who gargled with tap water or povidone–iodine three times each day experienced a reduction in upper respiratory tract infections compared with those who did not gargle.11 Another trial in England found that nasal cavity irrigation and throat gargling with hypertonic saline within 48 h of the onset of symptoms significantly reduced the duration of illness by 1.9 days, decreased medication usage by 36%, and lowered household transmission rates by 35%.12 During the COVID-19 pandemic, studies also suggested that saline, povidone–iodine, and antiseptic gargles could reduce the viral load or support symptom improvement.9,10 These studies support continued evaluation of gargling, but differences in populations, formulations, timings, and outcomes limit direct comparisons with the current pilgrimage-based pilot.
Among participants who completed the post-pilgrimage adherence assessment, more than two-thirds reported gargling twice daily almost every day, suggesting that the intervention was acceptable and could be incorporated into daily Umrah routines. However, only 22 of the 46 intervention participants completed the follow-up assessment, with a 52.2% attrition rate. This limits the generalizability of the adherence findings and raises the possibility of non-response bias as participants who were more adherent or more favorably engaged with the intervention may have been more likely to respond. Thus, although the reported adherence rate of 68.2% is encouraging, it should be interpreted with caution. Future studies should incorporate stronger follow-up strategies and real-time or objective adherence measures if feasible to provide a more accurate assessment of sustained use. Feasibility and adherence are essential considerations when evaluating non-pharmaceutical interventions because an intervention cannot be effective at the population level if it is not acceptable, practical, or sustainable.16
The intervention is also potentially scalable. The mouthwash used in this study was alcohol-free, inexpensive, and commercially available. Specialized equipment or technical training were not required, and the instructions were simple. These characteristics are important for public health interventions that target large numbers of pilgrims. A low-cost and readily accessible product may be more feasible for broader implementation than interventions that require clinical supervision or specialized resources, particularly in mass gathering settings where large-scale uptake depends on practicality, user acceptability, and the fit with the implementation context.17
The qualitative findings provided important insights into the factors that influenced adherence and acceptability. Many participants perceived gargling as beneficial for maintaining respiratory and oral health, and viewed it as a preventive measure rather than a treatment for existing symptoms. This distinction is important because preventive behaviors are influenced by perceived susceptibility to illness, perceived benefits, and practical ease of use.18 The positive perceptions expressed by participants suggest that pilgrims may be receptive to simple self-care interventions when they are framed as practical measures to maintain health during travel.
Religious and cultural motivation was identified as another important facilitator of gargling. Some participants associated gargling with Islamic teachings regarding cleanliness and oral hygiene, particularly the practice of siwak. This finding is especially relevant in the context of Umrah, where daily routines and personal behaviors are strongly influenced by religious values.19 Therefore, integrating faith-sensitive messages with public health education may improve acceptance and adherence to respiratory hygiene practices among pilgrims.
Despite generally positive perceptions, forgetfulness and busy schedules were the main barriers to adherence. Participants rarely expressed unwillingness to gargle, but instead most challenges were related to competing priorities, time constraints, and the fact that gargling had not yet become an established habit. These findings suggest that implementation strategies may be as important as the intervention itself. Thus, future studies should consider incorporating behavioral reinforcement strategies including mobile phone reminders, visual cues, group-based encouragement, and integrating gargling into existing daily routines, such as tooth brushing or preparation before sleep. Habit-based health behavior interventions emphasize repetition in a stable context and using contextual cues to support automaticity, and mobile reminders have been shown to improve adherence to various health behaviors.20
An important qualitative finding was the impact of respiratory symptoms on worship experience. Participants described discomfort during worship, reduced concentration during prayer, and decreased stamina for religious activities. In contrast to conventional respiratory infection studies that focused primarily on clinical outcomes, the present study highlights the broader consequences of respiratory illness during pilgrimage. This is particularly relevant because Hajj and Umrah involve prolonged physical activity, crowding, and exposure to environmental stressors, and respiratory symptoms are consistently reported as common health problems among pilgrims. In addition, upper respiratory tract infections have been shown to affect quality of life and daily functioning,21 supporting the interpretation that respiratory symptoms may interfere with comfort and functional performance during worship. In the context of Umrah, maintaining respiratory health may contribute to infection prevention but also to comfort, spiritual focus, and the overall quality of worship.
The utilization of a mixed-methods approach was a strength of this study. The quantitative findings alone indicated the limited effectiveness of the intervention, but the qualitative data provided a deeper understanding of the perceptions and motivations of participants, and behavioral barriers. These implementation-related insights are important for designing future intervention trials because successful preventive programs are dependent on biological efficacy and real-world adherence.
This study had some limitations. First, the small pragmatic sample was selected for pilot feasibility rather than powered to detect clinical efficacy. Second, allocation was based on pre-existing travel batches rather than individual randomization. Participants within a batch may have shared travel schedules, accommodation, exposure risks, and behavioral characteristics, and the two batches may have differed systematically in ways unrelated to the intervention. Thus, these cluster-level differences could have resulted in selection bias and confounding. Third, respiratory outcomes were self-reported and microbiological testing was not performed to confirm infections. Fourth, adherence data were available for only 22/46 intervention participants (47.8%), leading to a substantial risk of non-response bias and the probable overestimation of adherence if more compliant participants were more willing to respond. Fifth, post-pilgrimage acceptability and open-ended responses may have been affected by social desirability bias because the participants received education and repeated reminders from the study team, and thus they may have been more inclined to report favorable views of the intervention. Sixth, preventive practices independently adopted by control participants were not systematically measured at follow-up. Finally, all participants were Malaysian pilgrims of Malay ethnicity, limiting generalizability to pilgrims from other countries and cultural backgrounds.
Despite these limitations, this study obtained useful preliminary evidence regarding the feasibility and acceptability of antiseptic gargling among Umrah pilgrims. The findings support the need to conduct larger multicenter studies incorporating objective microbiological outcomes, validated symptom scores, and behavioral adherence measures. Future studies should also explore whether combining gargling with other respiratory hygiene measures, such as hand hygiene, mask use, and vaccination, may provide additional benefits in mass gathering settings.
Conclusion
Statistically significant reductions in respiratory symptoms were not observed, but antiseptic gargling was found to be acceptable, feasible, and generally well received among Malaysian Umrah pilgrims. The qualitative findings highlighted the importance of perceived health benefits, religious motivation, and behavioral factors in influencing adherence. Respiratory symptoms were also found to affect comfort, concentration, and stamina during worship. These findings support further evaluation of gargling as part of a broader respiratory hygiene strategy for pilgrims in larger multicenter studies incorporating objective microbiological outcomes and adherence-enhancing approaches.
Declaration of generative AI and AI-assisted technologies in the manuscript preparation process
During the preparation of this work, the authors used ChatGPT by OpenAI to assist with language editing, manuscript structuring, and refinement of wording. The authors reviewed and edited the output as needed and take full responsibility for the content of the published article.
Ethical approval
This study received ethical approval from the Research Ethics Committee of Universiti Sains Islam Malaysia (USIM) under approval number USIM/JKEP/2025-354.
Authors contributions
NAM conceptualized the study, supervised the project, and prepared the final draft of the manuscript. NB conducted data analysis and contributed to interpretation of the findings. II contributed to the initial idea and study concept. WSWS prepared the initial draft of the manuscript. All authors have critically reviewed and approved the final draft and are responsible for the content and similarity index of the manuscript.
Source of funding
External funding was not received for this study.
Conflict of interest
The authors have no conflicts of interest to declare.
Acknowledgment
The authors would like to thank all of the Umrah pilgrims who participated in this study.
Footnotes
Peer review under responsibility of Taibah University.
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