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IRCT20110827007422N7 IRCT 2026-02-14 Mazandaran University of Medical Sciences Effect of hypnotherapy on sexual dysfunction in menopausal women Study of the Effect of Hypnotherapy on Sexual dysfunction in Postmenopausal Women: A Randomized Controlled Clinical Trial 2025-09-23 anticipated 100 Complete https://irct.ir/trial/89038 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method in this study will initially be convenience sampling to identify eligible postmenopausal women. Subsequently, participants will be allocated into two groups, C (control group) and T (intervention group), using block randomization. The block randomization process will be performed using Microsoft Excel software. Therefore, participants will be placed into 25 blocks of four (total sample size = 100) using one of the following six types of 4-part blocks: TTCC, TCTC, TCCT, CCTT, CTCT, and CTTC, where T represents the intervention group and C represents the control group. Using Excel, 25 random numbers will be generated with the RANDBETWEEN function within the range of 1 to 6. Each generated number will correspond to one of the six block types (e.g., the number 1 corresponds to the CTTC block, 2 to CTCT, and so on), and participants will be assigned accordingly. For example, if four participants visit the center and two are to be assigned to the intervention group and two to the control group, a random number, for instance 2, is generated in Excel. Therefore, these four participants are assigned according to the CTCT block. In this block, the first participant is assigned to the control group, the second to the intervention group, the third to the control group, and the fourth to the intervention group. N/A Sexual dysfunction in Postmenopausal Women. Intervention group: This group includes postmenopausal women with sexual dysfunction. Hypnotherapy will be conducted by a trained researcher who has completed training at the Iranian Scientific Association of Clinical Hypnotherapy and holds a valid certification. Each participant in the intervention group will receive eight hypnotherapy sessions. The first session will be conducted face-to-face, individually, and will last 50 minutes. The remaining seven sessions will be held weekly, individually, online (via the WhatsApp virtual platform), each lasting 50 minutes. In addition to WhatsApp, two domestic messaging applications (Eitaa and Baleh) will also be included as alternative options.At the end of each session, an audio recording of the session will be sent to each participant so that they can perform hypnosis exercises at home at least twice daily (for 30 minutes each time) and record the number of practice sessions in a form provided to them. Once per week, participants will be contacted via telephone interview to report the frequency of performing the hypnosis exercises.The Female Sexual Function Index (FSFI) questionnaire will be administered at three time points: before the intervention, immediately after the intervention, and three months after the intervention.Treatment adherence in this study will be assessed using three criteria: the mean number of hypnotherapy sessions attended by participants in the intervention group, the number of participants who completed the at-home assignments, and the number of participants who fully completed the questionnaires.Treatment satisfaction will be measured using the Client Satisfaction Questionnaire-8 (CSQ-8), which evaluates overall satisfaction with the treatment, perceived usefulness of the sessions, the extent to which participants’ treatment needs were met, and the likelihood of recommending the intervention to others.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public monireh babouyeh darabi
Amir Mazandarani Street - Vesal Shirazi Street - Nasibe Nursing and Midwifery Faculty
Sari Iran (Islamic Republic of) 4816715793 +98 11 3324 6697 monirehbabouyehdarabi@gmail.com Mazandaran University of Medical Sciences scientific Dr.Zhila Ganji
Amir Mazandarani Street - Vesal Shirazi Street - Nasibe Nursing and Midwifery Faculty
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 7344 zhila.ganji@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Postmenopausal women with amenorrhea for 12 months or longer who are married. Aged between 45 and 55 years. Scoring below 26.5 on the Female Sexual Function Index (FSFI), indicating sexual dysfunction. Willing to participate in the study and able to provide written informed consent. Having stable mental health and no history of severe psychiatric disorders (such as uncontrolled depression, schizophrenia, or bipolar disorder). Not receiving hormone replacement therapy (HRT) that could affect sexual function. No history of severe chronic diseases such as uncontrolled diabetes, cardiovascular disease, thyroid disorders, multiple sclerosis (MS), etc. Having moderate to high hypnotizability according to the Stanford Hypnotic Susceptibility Scale. Having access to the internet and the ability to use mobile devices and online tools. Not currently using complementary therapies such as cognitive-behavioral therapy (CBT), yoga, meditation, or similar interventions. 45 years 55 years Female A history of recent gynecological or obstetric surgeries that may affect sexual function. Absence from more than two sessions during the study. Individuals with severe levels of stress and anxiety as assessed by the DASS-21 questionnaire. Current use or discontinuation within the past three months of any medications known to negatively affect sexual function, such as antidepressants, antipsychotics, antiepileptics, anticancer drugs, or newly identified drugs with adverse effects on sexual function. Unwillingness to continue participation in the study. Other Intervention group: This group includes postmenopausal women with sexual dysfunction. Hypnotherapy will be conducted by a trained researcher who has completed training at the Iranian Scientific Association of Clinical Hypnotherapy and holds a valid certification. Each participant in the intervention group will receive eight hypnotherapy sessions. The first session will be conducted face-to-face, individually, and will last 50 minutes. The remaining seven sessions will be held weekly, individually, online (via the WhatsApp virtual platform), each lasting 50 minutes. In addition to WhatsApp, two domestic messaging applications (Eitaa and Baleh) will also be included as alternative options.At the end of each session, an audio recording of the session will be sent to each participant so that they can perform hypnosis exercises at home at least twice daily (for 30 minutes each time) and record the number of practice sessions in a form provided to them. Once per week, participants will be contacted via telephone interview to report the frequency of performing the hypnosis exercises.The Female Sexual Function Index (FSFI) questionnaire will be administered at three time points: before the intervention, immediately after the intervention, and three months after the intervention.Treatment adherence in this study will be assessed using three criteria: the mean number of hypnotherapy sessions attended by participants in the intervention group, the number of participants who completed the at-home assignments, and the number of participants who fully completed the questionnaires.Treatment satisfaction will be measured using the Client Satisfaction Questionnaire-8 (CSQ-8), which evaluates overall satisfaction with the treatment, perceived usefulness of the sessions, the extent to which participants’ treatment needs were met, and the likelihood of recommending the intervention to others. Sexual dysfunction. Timepoint: Before the intervention, immediately after the intervention, and three months after the intervention. Method of measurement: Female Sexual Function Index (FSFI). Consent to intervention. Timepoint: 3 months after the intervention. Method of measurement: Client Satisfaction Questionnaire-8. Adherence to treatment. Timepoint: 3 months after the intervention. Method of measurement: The mean number of hypnotherapy sessions attended by women in the intervention group, the number of participants who completed the at-home assignments, and the number of participants who fully completed the questionnaires. Mazandaran University of Medical Sciences Approved 2026-01-31 Ethics committee of mazandaran University of medical sciences Deputy of Research and Technology of Mazandaran University of Medical Sciences, Moalem Square sari Mazandaran Iran (Islamic Republic of)