NCT06354283

Brief Summary

This study was conducted to investigate the effect of progressive muscle relaxation exercises on sexual satisfaction and functioning of women and their partners in women with low sexual satisfaction. Method: The single-blind, randomized controlled study was conducted between April 2023 and January 2024. The sample of the study was women with low sexual satisfaction and their partners were randomized into two groups as intervention and control. Each group consisted of 120 couples, n=60. The women in the intervention group were given progressive muscle relaxation techniques three times a week for four weeks. The results of the study focused on the effect on sexual satisfaction and functioning of men and women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

April 3, 2024

Last Update Submit

April 3, 2024

Conditions

Keywords

Sexual SatisfactionProgressive Muscle Relaxation ExercisesSexual Functioning

Outcome Measures

Primary Outcomes (1)

  • Sexual Satisfaction

    The scale consists of 20 items. The 5-point Likert-type scale is scored as (1) I am not satisfied at all (2) I am somewhat satisfied (3) I am moderately satisfied (4) I am very satisfied (5) I am extremely satisfied. The lowest score that can be obtained from the scale is 20 and the highest score is 100. The scale consists of a self-centered sub-dimension and a partner/ sexual activity-centered sub-dimension. These two subscales represent the New Sexual Satisfaction Scale. The self-centered sub-dimension consists of items 1-10 and the partner/ sexual activity-centered sub-dimension consists of items 11-20. Scoring is calculated by summing the items. A high score on the scale indicates good sexual satisfaction. There are no reverse scored items in the scale.

    Pre-intervention, 2nd and 4th weeks after intervention

Secondary Outcomes (1)

  • Sexual Function

    Pre-intervention, 2nd and 4th weeks after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Progressive muscle relaxation techniques were explained to the women from the couples assigned to the Intervention Group by a researcher. In addition to relaxation exercises, deep breathing movements were also explained to the women and progressive muscle relaxation exercises and breathing exercises were performed together. The importance of the exercises and how to do them were explained to the women for about 30 minutes by the researcher and then demonstrated practically for 30 minutes. Each progressive muscle relaxation exercise session lasted approximately 20-25 minutes. The women in the intervention group continued the exercises at home three times a week for four weeks. The women in the intervention group were telephoned once a week by the researcher to provide reminders and counseling regarding the study

Behavioral: Progressive Muscle Relaxation Exercises

Control

NO INTERVENTION

The study was announced on social media and online to identify women and men who met the sample selection criteria. Couples who scored between 20-40 on the New Sexual Satisfaction Scale for women and 11 or higher on the Arizona Sexual Life Scale for men and women were randomized into two groups. A data collection form was applied to the couples included in the sample. The Control Group was followed up by continuing the daily routine. At the end of two and four weeks, the New Sexual Satisfaction Scale and Arizona Sexual Life Scale were administered to all women and their partners.

Interventions

Progressive muscle relaxation techniques were explained to the women from the couples assigned to the Intervention Group by a researcher. In addition to relaxation exercises, deep breathing movements were also explained to the women and progressive muscle relaxation exercises and breathing exercises were performed together. The importance of the exercises and how to do them were explained to the women by the researcher for about 30 minutes and then demonstrated practically for 30 minutes. Each progressive muscle relaxation exercise session lasted approximately 20-25 minutes. The women in the intervention group continued the exercises at home three times a week for four weeks.

Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsWomen and their partners with low sexual satisfaction
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women who had active sexual life, were of childbearing age (18-35 years), had the same partner for the last year, had not given birth before, and scored between 20-40 on the New Sexual Satisfaction Scale were included.

You may not qualify if:

  • Women and their partners who had chronic gynecological diseases, who were using psychiatric medication for themselves and/or their partners, who were pregnant at the time of the study, who had diagnoses that hindered sexuality such as vaginismus, erectile dysfunction, etc., and who scored below 11 on the Arizona Sexual Life Scale were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Şule Bilgiç

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Orgasm

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The progressive relaxation intervention and follow-up was conducted by the researcher who was not blinded to the interventions (PSI). Randomization was performed by another academic who was not an investigator in the study. In order to avoid bias, the researcher who conducted the intervention did not participate in any step of the pre-test, post-test and statistical evaluation process. Group information was not shared with the statistician who performed the analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention Group and Control Group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 9, 2024

Study Start

April 10, 2023

Primary Completion

January 30, 2024

Study Completion

February 8, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

It is appropriate to present it after publication

Locations