The Effects of Psychosexual Education on Promoting Sexual Function, Genital Self-Image, and Sexual Distress among Women with Rokitansky Syndrome: A Randomized Controlled Clinical Trial

Vosoughi N, Maasoumi R, Mehrizi AA, Ghanbari Z. 

JPAG 2022; VOLUME 35, ISSUE 1, P73-81, February 2022

1. What were the inclusion and exclusion criteria for the study? What are some of the limitations from developing these criteria?

A. Participants were included in the study if they were Iranian, married and only wife, 15-49 years old, media literate with an Android phone and internet access, having medical records and procedures indicating the diagnosis of MRKH syndrome, the passing of at least 6 months since vaginal reconstruction, having had at least 6 months of vaginal intercourse, and not being enlisted for IVF, not having any chronic disease or drugs that would affect sexual function, and not having received psychosexual education before the intervention. Participants were excluded if they were unwilling to continue cooperation and not having read the chapters of the education content. These respondents may not be generalizable with the specific criteria seeking Iranian and married heterosexual participants. Self-selection bias may also be possible; volunteers to participate in the research inherently had higher motivation and readiness to engage, and the exclusion criteria are designed to decrease the drop-out rate in the process of the study.

2. This study was a randomized controlled clinical trial. What is randomization, and how did this study randomize their participants? What are the limitations of randomization?

A. Randomization refers to the process of assigning study participants to groups at random, such that each participants has an equal probability of being assigned to any group. The goal of randomization is to eliminate selection bias and to balance potential confounding factors. Participants in this study was randomized using blocks of 4. Using a block size of 4 for 2 treatment arms (example, A and B) will lead to 6 possible arrangements (AABB, BBAA, ABAB, BABA, BAAB, ABBA). One of the disadvantages of block randomization is that the next assignment may be predictable. In this study, the randomization sequence was created by a computer with the investigator not involved in the study intervention, thus allocation was further sealed by the researcher.

3. Consider some of the differences between a drug trial and an education trial. What are some of the limitations of an education trial, specifically the ability to blind?

A. In a drug trial, both researchers and participants may be blinded to the intervention. In an education trial, it is virtually impossible to blind participants or the investigators from the intervention. As a result, the participants undergoing the intervention may attempt to change or improve their behavior. Additionally, as participants would know what group they are in, there is also the risk of data contamination, which is when the effect of the treatment may be diluted by being made available to the control group. In this study, the intervention and control group members were advised to avoid talking to each other about the contents of the application if they had any interaction with each other.

4. What is the Cronbach a? How is it used? What is the purpose?

A. Cronbach a is also known as coefficient alpha or rho equivalent reliability. It is a measure on internal consistency between a set of survey items. The goal is to quantify the level of agreement on a standardized 0 to 1 scale. This measurement was crucial as the researchers utilized translated surveys.

5. In the LOTUS app the intervention group had what additional benefit, other than educational content? Could this have changed the analysis or research design?

A. The intervention group had the benefit of an online forum to ask questions. The researchers could have separated the groups into three (two interventions, education+forum, education and control).

6. What are some of the other ways that you as a provider can (or have in the past) promote sexual function and reduce sexual distress in patients with MRKH?

A. Clinicians can consider a variety of resources for the MRKH population, including patient hand-outs and reading material, a referral to a licensed professional such as a sex therapist, and support groups. Clinicians should also incorporate counseling of patients during regular outpatient visits, at time of diagnosis and at subsequent visits.