Women With Low Sexual SatisfactionNCT06354283
Progressive Muscle Relaxation Exercises Women With Low Sexual Satisfaction Sexual Satisfaction and Functioning of Women and Their Partners
A study testing Progressive Muscle Relaxation Exercises in people with Women With Low Sexual Satisfaction and Partners of Women With Low Sexual Satisfaction, run by Halic University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Women With Low Sexual Satisfaction, Partners of Women With Low Sexual Satisfaction
- What is being tested?
- Progressive Muscle Relaxation Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2023to 8 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Muscle Relaxation Exercises Applied to Women With Low Sexual Satisfaction on Sexual Satisfaction and Functioning of Women and Their Partners: A Randomized Controlled Trial
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.
Read the detailed description
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.
Hypotheses H1: Progressive muscle relaxation techniques increase sexual satisfaction in women with low sexual satisfaction.
H2: Progressive muscle relaxation techniques positively affect sexual function in women with low sexual satisfaction.
H3: Progressive muscle relaxation techniques increase sexual satisfaction of partners in women with low sexual satisfaction.
H4: Progressive muscle relaxation techniques positively affect sexual function of partners in women with low sexual satisfaction.
While the population of the study consisted of women aged 18-35 years, the minimum sample size was calculated using G Power. Accordingly, it was found that the number of women to be sampled should be 44 for each group, totaling 88 women. Considering that there would be losses, the sample was planned to be 60 couples for each group, totaling 120 couples. There were no losses during the study.
Sample Selection Criteria; Women who had an 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.
Sample Exclusion Criteria; Women and their partners who had chronic gynecological diseases, whose own and/or partner used psychiatric drugs, who were pregnant during the study, who had diagnoses that prevented sexuality such as vaginusmus, erectile dysfunction, etc., who scored below 11 on the Arizona Sexual Life Scale were not included in the study.
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.
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. The women in the intervention group were telephoned once a week by the researcher to provide reminders and counseling about the study (Progressive muscle relaxation steps were given as an additional file).
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.
- Being tested
- Progressive Muscle Relaxation Exercises
- Keywords
- Sexual Satisfaction, Progressive Muscle Relaxation Exercises, Sexual Functioning
- Medical subject headings
- Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention, 2nd and 4th weeks after intervention
Secondary outcomes (1)
Sexual Function
It was used to include women and men in the sample and to evaluate sexual function during follow-up. The scale, which has separate male and female forms, is filled in by the patients and no special training is required for its interpretation. The scale consists of five items on a six-point Likert scale with a score range of 5-30 and an increase in the total score indicates sexual dysfunction. According to Soykan, a scale score of ≥11 is the cut-off point for sexual dysfunction. In the validity and reliability study in Turkey, the scale was found to have high internal consistency and reliability with Cronbach's α values of 0.89-0.90 and to be valid in differentiating sexual dysfunction. In this study, it was 0.78 in men and 0.82 in women.
Measured: Pre-intervention, 2nd and 4th weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start10 Apr 2023
- Primary completion30 Jan 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Low Sexual SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group and Control Group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354283
- Sponsor's protocol ID
- Progresif
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is appropriate to present it after publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Exercises Applied to Women With Low Sexual Satisfaction on Sexual Satisfaction and Functioning of Women and Their Partners: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06354283
- Acronym / sponsor ID
- Progresif
- Keywords
- Sexual Satisfaction, Progressive Muscle Relaxation Exercises, Sexual Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Hypotheses H1: Progressive muscle relaxation techniques increase sexual satisfaction in women with low sexual satisfaction.
H2: Progressive muscle relaxation techniques positively affect sexual function in women with low sexual satisfaction.
H3: Progressive muscle relaxation techniques increase sexual satisfaction of partners in women with low sexual satisfaction.
H4: Progressive muscle relaxation techniques positively affect sexual function of partners in women with low sexual satisfaction.
While the population of the study consisted of women aged 18-35 years, the minimum sample size was calculated using G Power. Accordingly, it was found that the number of women to be sampled should be 44 for each group, totaling 88 women. Considering that there would be losses, the sample was planned to be 60 couples for each group, totaling 120 couples. There were no losses during the study.
Sample Selection Criteria; Women who had an 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.
Sample Exclusion Criteria; Women and their partners who had chronic gynecological diseases, whose own and/or partner used psychiatric drugs, who were pregnant during the study, who had diagnoses that prevented sexuality such as vaginusmus, erectile dysfunction, etc., who scored below 11 on the Arizona Sexual Life Scale were not included in the study.
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.
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. The women in the intervention group were telephoned once a week by the researcher to provide reminders and counseling about the study (Progressive muscle relaxation steps were given as an additional file).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention Group and Control Group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Progressive Muscle Relaxation ExercisesProgressive 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 |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Muscle Relaxation ExercisesProgressive 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. | Behavioural | Intervention |
Primary outcome
Sexual Satisfaction
Time frame: Pre-intervention, 2nd and 4th weeks after intervention
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.
1 secondary outcome
Sexual Function
Time frame: Pre-intervention, 2nd and 4th weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No. It is appropriate to present it after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation Exercises in people with Women With Low Sexual Satisfaction and Partners of Women With Low Sexual Satisfaction, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Satisfaction (time frame: Pre-intervention, 2nd and 4th weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.