Abstract
Introduction:
Vulvodynia is vulvar pain lasting at least 3-months without clear identifiable cause that may have other associated factors. The aim, to explore motivations of women participating in a double-blind randomized controlled trial of acupuncture for vulvodynia.
Methods:
Responses to the question: “Tell me about why you decided to participate in this study” were analyzed using conceptual content analysis to identify patterns in motivation for study participation.
Results:
Four patterns emerged: 1) desire to address uncontrolled pain, 2) desire for understanding, 3) wish to contribute to knowledge generation, and 4) need to remove cost barriers.
Conclusion:
Motivations indicate vulvodynia-specific aspects of acceptability of acupuncture.
Clinical Trial Registration:
Keywords: vulvodynia, vulvar pain, acupuncture, complementary integrative health
Introduction
Up to 7% of women have vulvodynia, disabling chronic vulvar pain of at least a 3-month duration without a clear identifiable cause that may have other associated factors.1 Vulvodynia is often accompanied by dyspareunia, painful intercourse, which renders sexual intercourse virtually impossible.2 Despite taking adjuvant drugs and opioids, women with vulvodynia reported 6.7/10 average pain intensity (average of current, least, and worst pain in the last 24 h).3 In one study, 60% of women used alcohol and 43% combined alcohol and analgesics, including opioids, to reduce their pain.3 Many vulvodynia treatments are inconsistently effective.1 Thus, treating vulvodynia can be “hit or miss,” leaving women desperate for relief.
Acupuncture has demonstrated efficacy for several chronic pain conditions.4,5 A pilot randomized controlled trial (RCT) for vulvodynia6 showed that acupuncture significantly reduced vulvar pain and dyspareunia and increased overall sexual function. We are in the fifth year of a National Institutes of Health-sponsored double-blind efficacy study of a 5-week trial of genuine acupuncture versus sham acupuncture for the treatment of vulvodynia (both acupuncturist and participant blinded to the needle type). Because little is known about why patients with chronic pain choose to participate in acupuncture research, we report on women's motivations to participate in this double-blind RCT of acupuncture for vulvodynia.
The Institutional Review Board (IRB) at the University of Illinois Chicago (UIC, IRB2017-0885) approved the RCT, and the IRB at the University of Florida approved the study of deidentified data as exempt (IRB201800566).
Methods
Design
After the 10th and final acupuncture session,7 participants were asked to respond to one question: “Tell me about why you decided to participate in this study.” Participants typed open-ended responses into the vulvodynia module of PAINReportIt,8 a computerized McGill Pain Questionnaire. Informed consent was obtained from all enrolled. Data collection and management were facilitated by the Research Electronic Data Capture (REDCap),9 hosted at UIC. This trial is registered in ClinicalTrials.gov, Identifier: NCT03364127.
Sample/setting
The inclusion criteria were as follows: 18 years of age or older, diagnosed with vulvodynia on-site by a pelvic examination, and never had acupuncture. The exclusion criteria were as follows: other pathologic causes of vulvar pain, pelvic pain, pregnancy, atrophic vaginitis, and concomitant use of massage, physical therapy, or additional acupuncture. This study is being conducted in the Integrative Medicine Research Lab at the UIC College of Nursing. Participants were recruited from the Chicagoland area.
Analysis
Participants' responses were analyzed using conceptual content analysis to code for existence and frequency of concepts reflecting motivation of study participation.
Results
The 50 participants were 20 to 52 years old (mean ± standard deviation = 29.0 ± 7.1) and predominately White, non-Hispanic, single, and educated beyond high school (Table 1). Four motivational patterns emerged from participants' responses on why they participated in the study. Representational quotes for each of these 4 patterns are provided (Table 2).
Table 1.
Characteristics of the Sample (N = 50)
| Variable | Category | Total (N = 50), n (%) |
|---|---|---|
| Marital status | Single | 29 (58) |
| Married/partnered | 18 (36) | |
| Widowed | 1 (2) | |
| Other | 2 (4) | |
| Race | White | 40 (82) |
| Black | 1 (2) | |
| Asian | 4 (8) | |
| Native American/Alaska Native | 1 (2) | |
| Other | 3 (6) | |
| Ethnicity | Hispanic | 10 (20) |
| Not Hispanic | 40 (80) | |
| Income | <51k | 25 (50) |
| 51–100k | 16 (32) | |
| >100k | 9 (18) | |
| Education | <HS, HS, vocational school | 5 (10) |
| Associates/some college | 2 (4) | |
| Bachelor's degree | 25 (52) | |
| Graduate or professional | 16 (33) | |
| Employment status | Unemployed | 1 (2) |
| Employed (part- or full-time) | 44 (88) | |
| Student | 5 (10) |
Table 2.
Representative Quotes for Each of the Four Motivational Patterns Reflecting Why Women Decided to Participate in This Acupuncture Study
| Characteristicsa | Quotes |
|---|---|
| A desire to address uncontrolled pain | |
| 37-year-olda White, Hispanic/Latino, income >100k | I've tried many things to reduce my vulvodynia pain, but nothing has worked. I want to try all my available options before accepting that my pain will not go away. |
| 24-year-old White, income 51–100k | I wanted to participate in this study in order to relieve my pain and not be anxious about having sex—because of the thought of being in pain. |
| 33-year-olda White, income >100k | I have had vulvodynia for over a decade, and I haven't had good luck with traditional treatment, or with even finding clinicians who are familiar working with it. I mostly ignore it, but I know that's not healthy. I thought this would be a good way to try something new and begin addressing it again. |
| 20-year-olda White, income <51k | I desperately want the pain to go away so I can feel like I can have a closer bond with my partner and relate to my peers. |
| 31-year-olda White, Hispanic/Latino, income 51–100k | I have been told that there is no treatment for vulva. I am in love with my husband, we used to have lot of sex and now our marriage is fallen apart. I feel less of a woman I cry out of nowhere my mood swings are crazy. I would love to feel how I used to; I would love to make love to him without having to worry about causing myself pain. If I have to volunteer to help other women or myself, I will not hesitate. No woman should feel less. |
| 28-year-olda White, income <51k | I've been suffering from vulvodynia for over four years and have tried a number of different treatments including medication and physical therapy. However, my pain has never gone away. I felt like it was time to explore some alternative treatments that might reduce the pain. For the most part, I've made some peace with the fact that my pain might never disappear. However, I still want to explore options that would lessen it. I know acupuncture has been used to successfully treat pain for other people in my life, so I wanted to try it as well. |
| A desire for understanding oneself | |
| 35-year-olda White, Hispanic/Latino, income <51k | To become more aware of my condition and try to find solutions to help it. |
| 32-year-old White, <51k | To achieve better understanding of my pain and options/methods for management. |
| 22-year-old Black, <51k | I had vaginal pain for a while and never understood why and I thought this study would provide answers, which it did. I also just wanted to contribute. |
| 22-year-old White, <51k | I've had a burning pain in my vagina over the past three years that has never been treated or diagnosed, besides once being told I should use lube during sex, even though I tried to make clear that was not the main problem I was experiencing. |
| A wish to contribute to knowledge generation | |
| 37-year-olda White, income 51–100k | Wanted to be a part of increasing the research understanding of treatment for vulvodynia. Also, so I could document it for my closed Facebook group. Also, for personal: maybe it would help me. |
| 23-year-olda Black, Hispanic/Latino, income 51–100k | I know how important research is to solve future needs. |
| 28-year-olda White, income 51–100k | I participated because I wish we had more research on this subject. I'm grateful to contribute to growing research and to help those currently suffering and hopefully help people from going without treatment and answers. |
| 31-year-olda White, income 51–100k | I wanted to try an alternative treatment. I also want to support this area of research that is traditionally neglected/overlooked since it mostly affects women or people with vulvas. |
| A need to remove cost barriers | |
| 25-year-old White, income <51k | I was hopeful that this would be the answer to my pain, and acupuncture can be very expensive on its own. |
| 56-year-olda White, income 51–100k | I'm hoping that acupuncture may someday be covered by HMO insurance. |
| 26-year-old White, income <51k | I want to be active in combatting my pain, but I've currently switched health insurance and don't have the money to pay for treatments out of pocket. I've also been curious about acupuncture. |
| 25-year-olda White, income >100k | Free/streamlined treatment I would not otherwise have had access to. I've tried multiple medications and physical therapy with little success, so I'm willing to do anything at this point! |
Married/partnered.
A desire to address uncontrolled pain was reported by 39 women (78%). Untreated and uncontrolled chronic pain was described as all-consuming and leaving women feeling desperate. Several linked their uncontrolled pain to negative effects on partner intimacy, their own mental health, and to poorer overall quality of life. One 29-year-old White woman wrote, “I have been dealing with vulvodynia for 7 years now. It consumes my life. It has cost me a lot of money, time, and intimacy with partners. I am willing to do almost anything for the pain to get better.” Many participants noted that nothing has worked for them in the past, so they are willing to try new treatments to reduce their pain.
A wish to contribute to knowledge generation was reported by 13 women (26%). Those noting this motivation ranged across all education levels. Many wanted to contribute to science, noting it would promote a greater understanding of vulvodynia and acupuncture as a potential treatment. Participation made them hope that solutions would be found to minimize the suffering for women with vulvodynia. A 28-year-old White woman expressed this sentiment by writing “I participated because I wish we had more research on this subject. I'm grateful to contribute to growing research and to help those currently suffering and hopefully help people from going without treatment and answers.”
A desire for understanding oneself was noted by seven women (14%). Many wanted to better learn about their own experience with vulvodynia and ways to manage their pain. Some had never even had a diagnosis or were not aware that their pain was abnormal. A 28-year-old Hispanic woman exemplified this when she wrote, “I didn't know that experiencing pain through inserting a tampon or going to the gynecologist and of course having sex wasn't the norm. I have been afraid of all of these things simply to avoid pain and when I saw the ad on the bus, I couldn't believe this was a condition of some sort that could be treated or tended to. It had made me completely reevaluate how I perceive my own pain and that's been strangely freeing!”
A need to remove cost barriers was expressed by 5 (10%) women, all identifying as White and from five different income brackets ranging from less than $11,000 to more than $100,000. Some were motived to participate because they could not afford to pay for acupuncture on their own because insurance did not cover it. One 26-year-old White woman wrote, “I want to be active in combatting my pain, but I've currently switched health insurance and don't have the money to pay for treatments out of pocket.” Another participant wrote that she hoped that acupuncture would someday be covered by insurance.
Limitations
The limitation of this study is that participants were asked why they chose to participate in the study after they completed the acupuncture intervention. Their responses may have differed depending on whether they had pain relief.
Discussion
Most participants cited their uncontrolled pain as motivation to participate. This finding is consistent with Li et al's10 findings that showed adults with sickle cell disease sought acupuncture to reduce uncontrolled pain. Importantly, until learning of and participating in this study, several women did not have a diagnosis or reason for their vulvar pain. This is consistent with Harlow and Stewart's findings that it takes visits to at least three providers for a diagnosis and that some women never get a diagnosis.11 Increased public health awareness as well as health care provider and student education regarding the existence of vulvodynia is warranted.
Further investigation is needed concerning women's experiences of living with uncontrolled vulvodynia. This includes several factors: lack of awareness that vulvar pain is abnormal, sharing their pain experiences with health care providers, and/or dismissal of experiences by providers. Future research is warranted into complex societal constructs related to stigma and lack of understanding of one's body, and how these societal constructs influence how women with vulvodynia view themselves and suffer in silence. Investigations into patient-reported outcomes should also aim to capture the experience of living with an undiagnosed pain condition. These insights will work to reduce stigma, enable better understanding of vulvodynia, and lead to new targeted treatments, including acupuncture. Many participants were committed to new knowledge generation so that others who suffer from vulvodynia may be helped.
Some women participated to reduce health care costs. Acupuncture is not currently covered by most third-party insurances and Medicaid and Medicare do not cover it for the treatment of vulvodynia.12 If this RCT demonstrates efficacy, then financial barriers to acupuncture must be addressed through the next step, conducting a hybrid effectiveness-implementation trial of acupuncture for vulvodynia. A pragmatic trial will enable embedding acupuncture for treating vulvodynia into the American health care system.13 Conducting pragmatic trials of acupuncture is a high research priority as delineated in the National Center for Complementary and Integrative Health 2021–2025 Strategic Plan.14 Importantly, pragmatic trials of acupuncture will impact health care policy regarding prompt third-party insurance, Medicaid, and Medicare reimbursement. This policy shift will enable acupuncture to be accessible to all and allow integration into conventional clinical care.
The motivations of participants in this study reflect several domains of Sekhon's Theoretical Framework of Acceptability.15 A desire to address uncontrolled pain and a desire for understanding oneself overlap with the constructs of affective attitudes or how the individual feels about the intervention and its perceived effectiveness. A wish to contribute to knowledge generation is similar to intervention coherence or a person's understanding of how the intervention and how science works as well as perceived effectiveness.15 The fourth pattern, a need to remove cost barriers, brings together Sekhon's categories of opportunity costs, the perceived benefits gained from engaging in the intervention as well as the burdens, or perceptions about the effort required to participate in the intervention.
Conclusion
The motivations of women who participated in this double-blind RCT of acupuncture indicate vulvodynia-specific aspects of acceptability of acupuncture for women with this chronic pain condition. These motivations and elements of acceptability can help guide future studies of acupuncture for vulvodynia as well as using this therapy to treat other chronic pain conditions.
Authors' Contributions
A.A.D., C.L.P., and J.M.S. were responsible for the acquisition, interpretation, and drafting of the article. A.A.D., A.D.S., L.A.B., Y.Y., C.L.P., and N.T. substantially contributed to the data analysis. M.L.S., J.E.G., W.H.K., M.M., M.T., H.Y., T.J.K., D.J.W., and D.F. critically revised the work for important intellectual content. All authors provided final approval of the version to be published and agree to be accountable for all aspects of the work.
Disclaimer
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Author Disclosure Statement
No competing financial interests exist.
Funding Information
This research was made possible by grant numbers R01HD091210 and F31NR019529 from the National Institutes of Health (NIH), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). and the National Institute for Nursing Research (NINR). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NICHD or NINR. The final peer-reviewed article is subject to the National Institutes of Health Public Access Policy. This publication is cosponsored by the Rockefeller University Heilbrunn Family Center for Research Nursing through the generosity of the Heilbrunn Family and the National Center for Advancing Translational Sciences, National Institutes of Health, through Rockefeller University, grant number UL1TR001866.
Dr. Diana J. Wilkie is the Founder and Chairman of eNURSING llc, a company without current ownership of the PAINReportIt software. The Center for Clinical and Translational Science, which hosted the data through REDCap, was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through grant number UL1TR002003.
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