Abstract
BACKGROUND:
The risk is on the level of blood pressure, and blood pressure is one of the prominent characteristics of preeclampsia. The aim of this study is to assess the effect of hypnosis on the pressure and blood pressure of pregnant women with preeclampsia.
MATERIALS AND METHODS:
In this controlled clinical trial study, 44 pregnant women from 20 to 32 weeks referred to Shahid Akbarabadi Hospital in Tehran in 2022 were randomly assigned to two intervention and control groups. Hypnotherapy was conducted individually and online for five sessions. Evaluation of performance and blood pressure (primary outcome) was done using the DASS-21 questionnaire and sphygmomanometer before, during maintenance, and 4 weeks after the intervention. Twenty people in each group entered the analysis stage. Independent t-test, Chi-square, analysis of variance with repeated measures and mixed model were used, and effect size (Cohen’s D) was used to evaluate the strength of the intervention effect. The data were entered into the SPSS software version 22 and a significance level of 0.05 was considered.
RESULTS:
The results showed that the two groups did not differ in terms of background changes (P = 0.757). The score after the intervention decreased by 10.25 (P < 0.001) and the time 1 month after the intervention decreased by 9.93 (P < 0.001). The blood pressure after the intervention was reduced by 7.90 (P < 0.001) and the blood pressure 1 month after the intervention by 7.52 (P < 0.001).
CONCLUSION:
It is suggested to use hypnotherapy as a complementary treatment to reduce anxiety and preeclampsia symptoms.
Keywords: Anxiety, blood pressure, hypnosis, preeclampsia
Introduction
Preeclampsia is the third most common cause of maternal mortality in the world and the second most common cause of maternal mortality in Iran.[1] It is diagnosed after the 20th week of pregnancy.[2] Preeclampsia includes 5–8% of all pregnancies and 20% of first pregnancies, this rate is 3% in Iran.[1] According to the World Health Organization (WHO), preeclampsia occurs mainly in developing countries and has maternal and fetal complications. In addition to short-term complications, preeclampsia causes long-term complications in the mother and baby, such as the risk of cardiovascular disease and neurological complications.[3] Blood pressure disorders are still considered as one of the most important unsolved issues in obstetrics,[4] many risk factors such as lifestyle, psychological aspects, high hemoglobin level, and sleep disorders have been proposed as the cause of this disease.[5] An increase in the amount of corticotropin and an increase in the activity in the sympathetic nervous system, which is caused by stress, has also been observed in women with preeclampsia.[6] Mental disorders lead to excessive activity of the sympathetic nervous system following the stimulation of the autonomic nervous system, which is considered a risk factor for preeclampsia.[7] According to Kurki et al.’s study,[8] stress and depression increase the risk of preeclampsia 2.3 to 2.5 times. Anxiety and depression during pregnancy due to changes in the release of vasoactive hormones or other neuroendocrine neurotransmitters can lead to an increase in the risk of gestational hypertension. One of the major problems that midwives as a member of the health care team always witness is the presence of anxiety in pregnant women.[9,10] Pregnancy is a stressful situation for most women, and women’s reactions to them are different, and it can show itself in the form of high blood pressure in pregnant women. Therefore, high blood pressure is one of the complications of psychosomatic disorders, which is related to the level of perceived stress and anxiety.[11] The response to stress is one of the main functions of the hypothalamus–pituitary–adrenal axis, which changes during pregnancy, and the major part of this change is due to the effect of the placental corticotropin hormone.[12,13] An increase in placental corticotropin stimulates the hypothalamus–pituitary–adrenal axis, which results in the secretion of cortisol hormone from the adrenal gland and an increase in its blood level. Regarding the release of cortisol during pregnancy, total cortisol increased with the progress of pregnancy and its amount is more than that of non-pregnant women. The hormone cortisol, which is released during stress, can increase vasoconstriction. Also, high blood pressure, as one of the symptoms of preeclampsia, can be caused by vasoconstriction caused by stress and anxiety. Therefore, a mother who is stressed or anxious is more exposed to high blood pressure disorders.[14,15] It is necessary to manage this process using an effective strategy. Anxiety and blood pressure in pregnancy can be managed using drug and non-drug treatments. Drug treatments may have adverse effects on the fetus and mother. Currently, methods such as music therapy,[13] psychological educational intervention,[14] cognitive behavioral intervention[15] have been used to reduce anxiety and blood pressure in women with preeclampsia, as well as hypnosis to control anxiety in pregnant women.[16] and lowering blood pressure[17] have been used. Hypnosis is a natural activity of the normal mind through which attention is focused, critical judgment is relatively suspended and awareness of the environment is reduced. Hypnosis with conditioned reflexes, the involvement of the limbic and hypothalamus regions of the brain increases the ability of the right hemisphere of the brain by ascending. Initially, 40 Hz beta and then the increase in beta waves in the brain, and as a result, increases suggestibility and motivation to do work.[15,16,17,18] It has been mentioned in studies that the immune system may be affected by psychological interventions such as hypnosis and that hypnosis affects the psychological symptoms of patients through this mechanism. Improving the subconscious mind that the child in the womb is a part of the mother’s body can prevent the antigen–antibody response. Hypnotic conditions cause the production of enkephalin, gamma amniobutyric acid, which has the function of reducing anxiety and frees the body from tension.[19,20,21] Hypnosis stimulates the parasympathetic nerves, and parasympathetic stimulation affects the smooth wall of the vessels, which is composed of smooth muscles, and the diameter of the vessels increases with parasympathetic stimulation. Therefore, blood flow increases. and finally, it lowers blood pressure.[22,23,24,25,26] Previous studies on the effect of hypnosis on anxiety were conducted in normal pregnancy, not preeclampsia.[27,28,29] In addition, in a study that examined the effect of hypnosis on blood pressure, the factor of anxiety was not examined.[30] However, in case–control and cohort studies, anxiety has been suggested as a risk factor for increased blood pressure and the incidence of preeclampsia.[31] It seems that it is necessary to measure the clinical performance of both variables as a primary outcome together. Therefore, considering the known side effects of stress and anxiety, and blood pressure in the mother and fetus, it is important to use non-pharmacological methods to reduce anxiety and blood pressure, and use various techniques to deal with stress and manage it. The purpose of this research is to determine the effect of hypnosis on anxiety and blood pressure in women with preeclampsia. It is hoped that by conducting this research, we can take an effective step towards reducing the psychological symptoms and complications of pre-eclampsia and have a worthy contribution to the realization of the goals of the healthy childbearing policy of the health system.
Method
Study design and setting
The current study is a double-blind clinical pilot study with a control group. This study was conducted in Tehran’s Akbarabadi Hospital on pregnant mothers with preeclampsia in 2022. This study has received its code of ethics from the Mazandaran Medical Sciences Ethics Committee.
Study participants and sampling
Considering the comparison of the average of two groups in this study, the following formula was used for the sample size. In this formula, N is the total number of samples required, r is the ratio of the intervention group to the control group, σp2 and is the integrated variance of the two groups.
Inclusion criteria for this study
Having mild pre-eclampsia (diagnosed by a gynecologist), diagnosis criteria (blood pressure equal to or greater than 140/90 mmHg to 110/160 mmHg after the 20th week of pregnancy, and proteinuria 1+), gestational age from 20 to 32 weeks absence of fetal distress[32] singleton pregnancy, reading and writing literacy, mild to moderate anxiety score (score 14 and below),[33] having general health (score lower than 23)[15,16] and consent to participate in the research.
Exit criteria
Suffering from depression based on information obtained from the Beck Depression Scale (score greater than 9), participating in any educational and counseling programs related to pregnancy and childbirth anxiety up to 5 months before entering the study and during the study, taking psychiatric drugs (current consumption) according to the patient’s medical record, the presence of severe depression or thoughts of suicide or harming others, mother’s addiction, spotting, cerclage, the presence of fever in the last three days,[27] the presence of uncontrolled seizures, the presence of psychosis[33] and it was unwillingness to continue cooperation.
Data collection tool and technique
In this study, demographic-fertility-medical questionnaire, general health questionnaire, DASS-21 anxiety questionnaire and Beck depression questionnaire, sphygmomanometer, stethoscope, meter and scale were used in this study. Maternal anxiety and blood pressure were measured as primary outcomes using the DASS-21 questionnaire and sphygmomanometer.
Demographic-fertility-medical form
The demographic-fertility-medical information form, which was designed with a wide review of related texts and the opinion of the research team, includes the following questions. Age, education, occupation, gestational age, number of pregnancies, weight, height, pulse, assessment of a person’s monthly income adequacy, assessment of a person’s socio-economic class, degree of satisfaction of a person’s socioeconomic class, residential home ownership status, medical insurance status, and supplementary insurance status.
Depression, anxiety, stress scale (DASS-21)
This questionnaire was created by Lavibond in 1995 and has two forms. Its original form has 42 statements that evaluate each of the mental constructs of depression, anxiety, and stress by 14 different statements. Its short form contains 21 statements, each of the 7 statements measures a factor or psychological instrument. The subject should mark the intensity of the symptoms raised in each substance that he experienced during the last week. Each question has a Likert scale between 0 and 30. This questionnaire is a shortened form of the main scale (42 questions), the final score of each subscale should be doubled. Antony et al.[34] in 1998 by examining Cronbach’s alpha for depression, anxiety, and stress scales reported 0.94, 0.87, and 0.91, respectively. In Iran, Cronbach’s alpha coefficient for this scale in a sample of 7,017 people in Iran has been reported as follows: depression is 0.81, anxiety is 0.73, and stress is 0.81.[32] validity and reliability of this questionnaire in Iran by Samani and Jokar[33] In this study, the reliability of this questionnaire was investigated and the evaluation in the group of pregnant mothers was evaluated as 0.99 after 2 weeks.
Depression instrument
Beck’s questionnaire is used to check the state of mother’s depression. The Beck Depression Inventory (BDI) consists of 21 questions that assess depression symptoms such as sadness, guilt, loss of interest, social withdrawal, and suicidal thoughts. This tool examines mood over the previous 2 weeks. The items of this questionnaire include four options and are scored on a scale of 0 to 3, and thus the total score changes between zero and 63.[35]
General health questionnaire
It was invented by Goldenberg in 1972 and the purpose of its design was to discover and identify these disorders in the clients of medical centers. This questionnaire has had a significant impact on the progress of behavioral science and psychiatry research and has been translated into different languages.[36,37] This tool detects acute mental disorders (less than two weeks) and is sensitive to transient disorders.[37] This questionnaire was initially designed as 60 items, but today there are several shortened versions that include General, GHQ-20, GHQ-28, Health Questionnaire-30 (GHQ-30), GHQ-12.[36,38,39,40] Studies conducted in different countries of the world in the field of validation of forms 28, 12, and 60 questions of the public health questionnaire have indicated the high reliability and validity of the questionnaire.[41] In the study by Ebadi et al.,[42] by checking the reliability of the questionnaire using the internal consistency method, Cronbach’s alpha coefficient was obtained as 0.87.
After approving the project and obtaining the code of ethics, the researcher according to the entry criteria checklist and the absence of high anxiety and the absence of depression (according to the DASS-21 questionnaire, which is a score of 15 and above, and the absence of depression according to the question Back letter score more than 9 includes it) were selected. Informed written consent was obtained from pregnant mothers and their husbands.
Random allocation
To randomly assign the samples to two groups of 22, the block method was used. For this purpose, the samples were divided into 15 blocks of four. The blocks will be TTCC, TCTC, TCCT, CCTT, CTCT, CTTC, where T is for the intervention group and C is for the control group. The numbers were randomly generated with the RANDBETWEEN command in Excel and in the range of 0 to 6. According to the production values, one of the blocks (for a production number between 0 and 1 CTTC block, for a production number between 1 and 2 CTCT blocks, and so on) was selected and the samples were allocated accordingly.
Intervention
First, demographic and medical information was asked, and then the depression questionnaire and DASS-21 were measured for all people in two groups. In case of depression, they are excluded from the study. Blood pressure was recorded. Hypnosis treatment was performed by a student who has been trained in the Clinical Hypnotherapy Association of Iran in Tehran and has a valid certificate. In group A, the control group of mothers received routine ward treatment and did not receive any non-pharmacological intervention. In group B, in addition to routine treatment, they received hypnosis, and mothers were taught self-hypnosis and a self-hypnosis CD prepared by the researcher was given to the mother.[31] For each subject of the intervention group, five hypnosis sessions[23] were held individually and online (through WhatsApp virtual network) for 45 to 60 min[43] each session [Table 1]. There were five sessions twice a week. If the patient was discharged, the sessions were continued outside the hospital at a suitable place in the patient’s home with the presence of a companion, and the sessions were recorded and given to the patients to listen to daily at home. They were checked. Their blood pressure was also measured by the health care provider and sent to the researcher [Diagram 1].
Table 1.
Intervention sessions
| Sessions | Subject |
|---|---|
| Session 1 | Review sessions and practice self-hypnosis hypnosis and its deepening for stressed areas of the body |
| Session 2 | Review sessions and practice self-hypnosis hypnosis and its deepening for stressed areas of the body |
| Session 3 | Review sessions and practice self-hypnosis hypnosis and its deepening for stressed areas of the body |
| Session 4 | Review sessions and practice self-hypnosis hypnosis and its deepening for stressed areas of the body |
| Session 5 | Review sessions and practice self-hypnosis hypnosis and its deepening for stressed areas of the body |
Diagram 1.
CONSORT
Data analysis
In this study, descriptive and inferential statistical methods were used to analyze the data. Descriptive indices such as mean, standard deviation, frequency, and percentage were used. For inferential analysis, at first, the hypothesis of normality of the variables was investigated using the Shapiro–Wilk test. For most variables of anxiety, normal distribution was maintained, but not normal for blood pressure, BY drawing the figure for blood pressure, it was almost similar to normal for some variables. The results of both parametric and non-parametric approaches were extracted and the same results were obtained in both methods. Because the results of both parametric and non-parametric approaches are the same, the results of the parametric test were presented for data analysis. Repeated measures tests and Bonferroni’s approximate test were used, and the effect size was used to evaluate the strength of the study effect. Also, to check the lasting effect of the intervention, the follow-up of the participants was continued for 1 month, to compare the average anxiety and blood pressure over time and not to lose the information of the people who did not participate until the end of the study (according to the treatment intention analysis and the possibility of incomplete data), mixed models were used. SPSS version 22 software was used for analysis and a significance level of 5% is considered.
Ethical consideration
At the end of the follow-up study, a meeting was held to familiarize the control group with hypnotherapy, so that this group would become familiar with this method of treatment. At the end of the sessions, the contents of the sessions were provided to the intervention and control groups. People who had anxiety disorder or acute depression and could not participate in the study according to the inclusion criteria were referred for treatment. The ethics code of this research was taken from the Ethics Committee of Mazandaran University of Medical Sciences. After that, the IRCT code was received from the Iranian clinical trial system. Written and informed consent was obtained from participants.
Code of ethics: IR.MAZUMS..REC.1400.9186.
IRCT code: IRCT20110827007422N3.
Results
The results showed that in terms of education and occupation, the majority of the participants had a diploma and were housewives. The distribution of background variables was the same between the intervention and control groups, and no statistically significant difference was observed between the two groups before the intervention. Demographic characteristics are presented in Table 2.
Table 2.
Demographic characteristics of the intervention and control groups
| P + | Control n (%) | Intervention n (%) | Total n (%) | Qualitative variable | |
|---|---|---|---|---|---|
| 0.101 | 3 (13.6) | 6 (27.3) | 9 (20.5) | Under diploma | Education |
| 15 (68.2) | 8 (36.4) | 23 (52.3) | Diploma | ||
| 4 (18.2) | 8 (37.3) | 12 (27.2) | Higher | ||
| 0.412 | 20 (91.9) | 17 (77.3) | 37 (84.1) | Housewife | Job |
| 2 (9.1) | 5 (22.7) | 7 (15.9) | Employee | ||
| 0.747 | 8 (36.4) | 6 (27.3) | 14 (31.8) | No | History of gestational |
| 14 (63.6) | 16 (72.7) | 30 (68.2) | Yes sir | hypertension | |
| 0.069 | 7 (31.8) | 14 (63.6) | 21 (47.7) | No | Prenatal class |
| 15 (68.2) | 8 (36.4) | 23 (52.3) | Yes sir | ||
| 0.345 | 1 (4.5) | 4 (18.2) | 5 (11.4) | Owner | home |
| 21 (95.5) | 18 (81.8) | 39 (88.6) | Tenant | ||
| >0.999 | 4 (18.2) | 4 (18.2) | 8 (18.2) | Insufficient | Income adequacy |
| 15 (68.2) | 16 (72.7) | 31 (70.5) | Until the some | ||
| 3 (13.6) | 2 (9.1) | 5 (11.4) | Coffee | ||
| 0.311 | 3 (13.6) | 4 (18.2) | 7 (15.9) | Insufficient | Satisfaction with income |
| 18 (81.9) | 14 (63.6) | 32 (72.7) | Until the some | ||
| 1 (4.5) | 4 (18.2) | 5 (11.4) | Coffee | ||
|
| |||||
| P* | Mean±SD | Mean±SD | Mean±SD | Quantitative variable | |
|
| |||||
| 0.940 | 26.95±3.83 | 26.86±4.09 | 26.91±3.92 | - | Mother’s age |
| 0.242 | 31.45±1.82 | 30.73±2.23 | 31.09±2.04 | - | Gestational age |
| 0.138 | 31.0±4.48 | 28.61±5.90 | 29.81±5.31 | - | BMI |
| 0.073 | 3.09±1.31 | 3.91±1.63 | 3.50±1.52 | Gravida | |
| 0.166 | 1.19±0.81 | 1.54±0.79 | 1.36±0.84 | Number of children | |
| 0.462 | 1.05±1.0 | 1.27±1.03 | 1.16±1.01 | Number of abortions | |
To compare the average anxiety score before the intervention, immediately after the intervention and 1 month after the intervention in the hypnotherapy intervention group, repeated measures analysis of variance was used. The results indicated that the intervention of hypnotherapy is an effective factor in the anxiety score (P = 0.001). In fact, in the intervention group, the average anxiety score gradually decreased over time and these changes were statistically significant. The average anxiety score in the stage immediately after the intervention and 1 month after the intervention was reduced by 5.41 points compared to the stage before the intervention [Table 3].
Table 3.
Comparison of the mean and standard deviation of the anxiety score before the intervention, immediately after the intervention, and 1 month after the intervention in the intervention group
| Significant level with repeated measures analysis of variance | Correlation (r) | Effect size (Cohen’s d) | Standard deviation±mean | Anxiety |
|---|---|---|---|---|
| 0.001 | - | Reference | 63.77±3.99 | Before intervention |
| 0/94 | 5.41 | 09.3±44.45 | Immediately after the intervention | |
| 0/94 | 5.41 | 3.05±44.55 | One month after the intervention |
To compare the effect of group (intervention and control) and time (before the intervention, immediately after the intervention and 1 month after the intervention) on the mean of the anxiety variable, the mixed models test was used. The results of the table show that the anxiety score of pregnant women in the control group is significantly higher than that of pregnant women in the intervention group by 11.31 units. Also, the anxiety score in the stage immediately after the intervention and 1 month after the intervention was significantly reduced compared to the stage before the intervention by 10.25 units and 9.93 units, respectively [Table 4].
Table 4.
Comparison of the effect of group (intervention and control) and time (before the intervention, immediately after the intervention and one month after the intervention) on the mean of the anxiety variable using mixed model
| Significance level* | Parent statistics | 95% Confidence interval of beta coefficient | Standard error | Beta coefficient | Parameter | |
|---|---|---|---|---|---|---|
| - | - | - | - | Reference | Intervention | Group |
| 0.001 | 120.5 | 9.29-13.32 | 1.031 | 11.31 | Control | |
| - | - | - | - | Reference | Before intervention | Time |
| 0.001 | 35.9 | -13/60_6.90 | 1.71 | -10.21 | Immediately after the intervention | |
| 0.001 | 3/33 | -13/60_6.95 | 1.72 | -9.93 | One month after the intervention | |
*Mixed model
To compare the average blood pressure score before the intervention, immediately after the intervention and 1 month after the intervention in the hypnotherapy intervention group, repeated measures analysis of variance was used. The results indicated that hypnotherapy intervention is an effective factor on blood pressure score (P = 0.001). In fact, in the intervention group, the average score of blood pressure gradually decreased over time, and these changes were statistically significant. The average blood pressure score in the stage immediately after the intervention and 1 month after the intervention was reduced by 3.11 and 3.10 units, respectively, compared to the stage before the intervention [Table 5].
Table 5.
Comparison of the average blood pressure score before the intervention, immediately after the intervention and one month after the intervention in the intervention group
| Significant level with repeated measures analysis of variance | Correlation (r) | Effect size (Cohen’s d) | Standard deviation±mean | Blood pressure |
|---|---|---|---|---|
| 0.001 | - | Reference | 139.95±4.01 | Before intervention |
| 0.84 | 3.11 | 126.78±4.45 | Immediately after the intervention | |
| 0.84 | 3.10 | 126.78±4.46 | One month after the intervention |
*Repeated measure ANOVA
To compare the effect of group (intervention and control) and time (before the intervention, immediately after the intervention and 1 month after the intervention) on the average score of the blood pressure variable, the mixed models test was used. The results of the table show that the blood pressure score of pregnant women in the control group is 9.59 units significantly higher than that of pregnant women in the intervention group. Also, the blood pressure score in the stage immediately after the intervention and 1 month after the intervention compared to the stage before the intervention was significantly reduced by 7.90 units and 7.52 units, respectively [Table 6].
Table 6.
Comparison of the effect of group (intervention and control) and time (before the intervention, immediately after the intervention and one month after the intervention) on the mean score of the blood pressure variable using a mixed model
| Significance level* | Parent statistics | 95% Confidence interval of beta coefficient | Standard error | Beta coefficient | Parameter | |
|---|---|---|---|---|---|---|
| - | - | - | - | Reference | Intervention | Group |
| 0.001 | 75.4 | 7.43_11.76 | 1.10 | 9.59 | Control | |
| - | - | - | - | Reference | Before intervention | Time |
| 0.001 | 57.6 | -9.94_-5.76 | 1.04 | -7.90 | Immediately after the intervention | |
| 0.001 | 45.9 | -9.70_-5.34 | 11/1 | 7/52- | One month after the intervention | |
*Mixed model
Discussion
High blood pressure is one of the most common disorders during pregnancy and the main cause of maternal and fetal deaths and illnesses all over the world. Blood pressure disorders in general are reported in 12–22% of pregnancies, and in Iran in 2015, the prevalence of pre-eclampsia is 5.2%.[2,44,45] In the present study, by performing hypnosis, blood pressure and anxiety were significantly reduced after the intervention and during follow-up in the intervention group compared to the control group. The results of the present study were carried out with a two-group semi-experimental study with a pre-test-post-test design by Khuzaiyah et al. as the effects of hypnotic relaxation on fetal heart rate and vital signs in pregnant women with pre-eclampsia in 2020 in Indonesia. It has been consistent, in this study, by performing hypnosis, the heart rate of the fetus and the vital signs of the mother were normalized, which indicates the effect of hypnosis on anxiety and psychological factors.[30] Another semi-experimental two-group pre-test-post-test study was conducted by Beevi et al.[31] with the title “The effect of hypnosis intervention in reducing psychological and physical symptoms during pregnancy” in 2016 in the Teaching Hospital of Kuala Lumpur, Malaysia. The purpose of this study was to determine the effect of hypnosis intervention in reducing physical and mental symptoms during pregnancy, the results showed that stress and anxiety symptoms decreased significantly for the experimental group, but not for the control group. Although the mean difference in depressive symptoms was not significant, the experimental group had fewer symptoms in stage 3. The results of physical symptoms showed significant differences at time 3, indicating a reduction in the experience of physical symptoms for experimental group participants. This study showed that hypnosis intervention during pregnancy helps to reduce physical and psychological symptoms during pregnancy. As it can be seen, the results of this study are in line with the results of our study and we see the effect of hypnosis on different psychological dimensions in pregnant women. A study by Legrand et al.,[46] entitled “Investigating the effect of hypnosis during pregnancy: A psychological-physical study on maternal stress,” was conducted in 2017. The purpose of this study was whether hypnosis can change the pattern and timing of maternal and fetal stress. According to the results of the study, they found that a short-term hypnotherapy intervention promises to relieve prenatal stress. The result of this study was in line with our study and in both studies hypnosis is effective in reducing the intensity of psychological factors.
A semi-experimental study of a pre-test-post-test group was conducted by Heydarian et al. 2016 as the effect of hypnotherapy on pre-eclampsia in pregnant women in 2017 at Jambar Hospital, Indonesia. The purpose of this study was to determine the effect of hypnotherapy on the development of pre-eclampsia. These results show that the effect of hypnosis can be observed in reducing the symptoms of pre-eclampsia. They found that hypnotherapy along with drug management has a positive effect on pre-eclampsia symptoms compared to drug therapy alone. This study is also in line with our study, and in this study, pre-eclampsia symptoms such as blood pressure were reduced by performing hypnosis.[47] In 2016, Nickel et al.[48] conducted a study in Helsinki with the aim of determining the effect of progressive muscle relaxation on changes in blood pressure, pulmonary parameters, heart rate, anger and quality of life in relation to the health of pregnant women with pulmonary asthma. They found that systolic blood pressure significantly decreases after muscle relaxation, but they did not state a result about diastolic blood pressure. Part of the results of this study are in line with our report, and the reason for the discrepancy in another part of it could be the type of intervention. Also, in 2016, Najafian and Golestan Hashemi conducted a study in Isfahan with the aim of comparing the effect of muscle relaxation and muscle relaxation with biofeedback on blood pressure and concluded that systolic and diastolic blood pressures decrease after muscle relaxation.[36] In another study conducted by Hahn et al. in 2010 in London with the aim of determining the effect of muscle relaxation alone or combined with biofeedback in reducing blood pressure and preventing hospitalization and comparing the outcome of pregnancy, they also found that systolic blood pressure after 6 weeks of muscle relaxation, decreased, which is consistent with the results of the present study. However, diastolic blood pressure did not show any difference from before the intervention. This issue is not consistent with the results of the present study.[37] The reason for the discrepancy and inconsistency of these results can be, firstly, the different types of intervention and secondly, the lack of use of antihypertensive drugs along with psychological treatment, which may cause desperation in a pregnant mother and mild psychological disorder. In the study of Mokaberian et al. in 2021, it was reported that the methods of progressive muscle relaxation and mental imagery have a positive and modulating effect on mental functions, endocrine and exocrine glands, and the cardiovascular system.[38] In 2008, Kass et al. conducted a semi-experimental study aimed at measuring the effects of self-hypnosis on pregnancy blood pressure. They conducted the study in a statistical population was hypertensive women who had relatively high blood pressure and mild hypertension. In this study, it was shown that the people who participated in the study compared to the people who were in the control group, only two people needed to take. They had medicine, but in the control group, 12 people needed to take medicine. It has been observed that systole blood pressure was 1.2 and diastole 0.7 was lower for people in the control group. The results of this study suggest that hypnosis can be a complementary treatment for controlling blood pressure in pregnancy. The results of this study are completely consistent with the results of the study.[39]
Limitation and recommendation
Examining the types of biases in the current clinical trial study shows these results, considering that the randomization process in the current study leads to the participation of qualified people in the study (participants have the same opportunity and chance to be included in it, each one of the intervention and control group) so the risk of selection bias in the study is reduced. The consultative nature of the intervention and the absence of blinding, and concealment of allocation status Participants from the researcher's point of view, implementation bias made the study possible (the present study is a double-blind study and from the point of view of the outcome evaluator and the data analysis of the study was done blind). Also, the evaluation and implementation of the hippotherapy protocol was done by the researcher and this indicates the diagnosis bias in the study, but because the data were collected using the questionnaires completed by the participants, it seems that the mentioned bias did not harm the study. Contamination bias is one of the biases that can occur in clinical trials.[40,49,50] This bias happens when the control group receives the intervention in the experiment, this may have happened inadvertently in the present study. The result of this bias will lead to the reduction of the effect size difference between the two groups. Failure to follow up and continue to participate in the research if it is more than 20%, can cause dropout bias in the study,[51,52,53] which is not the case in the present study. Also, the research design of the current study in the system of the International Clinical Trial Registration Center of Iran caused the reporting bias to be minimized. Among the limitations of the present study, the following can be mentioned. 1) Meetings could not be held in person due to the corona virus epidemic, 2) among other important things that were mentioned and recorded in the study as intervention, but due to the small number of research samples, it was not possible to exclude participants, body mass index, history of preeclampsia, history of hypertension before pregnancy and history of pre-eclampsia in the family, 3) due to the fact that in this study all questionnaires were completed by the participants in the form of self-report, it is possible that the reports of the participants about the burden of care and stress, the quality of life of the patients are different from the reality. Of course, it is necessary to explain that the intervening research team tried to control this limitation by assuring the participants that the information would remain confidential. 4) Sampling was performed during the COVID-19 epidemic, which can double the stress of pregnant mothers and affect the results of the study (of course, online interventions have been tried to control this). 5) The current research was conducted in educational and treatment centers, which can be effective in sampling (because people who refer to this hospital will be from the middle class and below). One of the important strengths in this study was holding classes in person and on the phone and consistently (weekly). In this study, participants were divided into two control and intervention groups using random allocation. To motivate the participants and accompany them until the end of the sessions, the content presented in the sessions before the start of the intervention was written by the researcher in the form of a protocol and in addition to the research team, four expert psychiatrists checked its validity. In this way, the content of the sessions was developed according to the needs of pregnant mothers, and this prevented the dropout of participants. Things such as the history of mental illness in the patient, receiving information from any source other than intervention sessions, and multiple and high-risk pregnancies were considered as exclusion criteria due to their great importance and affecting the study results. Examining two outcomes immediately after the sessions and during follow-up is among the other strengths of this study. The main tool of the research (DASS21 questionnaire in the group of pregnant mothers, its reliability was examined at 2-week intervals).
Conclusion
The results of this study indicate the effect of consistent and weekly hypnotherapy sessions on anxiety and blood pressure in pregnancy. In this way, according to the effect of the intervention, it is suggested to use this complementary treatment to reduce the symptoms of pre-eclampsia along with drug treatment.
Abbreviations
The Beck Depression Inventory (BDI), General health questionnaire (GHQ).
Application
According to the results of this study, it is possible to help in designing and developing educational interventions based on stronger evidence to manage hypertension due to pregnancy and pre-eclampsia.
Financial support and sponsorship
This article has been extracted from a master thesis and funded by the Clinical Research and Development Unit of the Research Deputy of Mazandaran University of Medical Sciences. Mazandaran University of Medical Sciences played a role in providing financial resources for this study.
Conflicts of interest
There are no conflicts of interest.
Acknowledgments
The study protocol was approved by the ethics committee of the Mazandaran University of Medical Sciences by Code: IR.MAZUMS.REC.1400.9186. The authors sincerely appreciate Deputy of Research and Technology at the Mazandaran University of Medical Sciences, IRAN which approved the project.
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