- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04900194
The Effect of Mindfulness-based Sexual Counseling on Sexual Distress in Pregnant Women
May 23, 2021 updated by: Sıdıka Özlem CENGİZHAN, Inonu University
The Effect of Mindfulness-based Sexual Counseling on Sexual Distress, Attitudes Towards Sexuality and Body Image Concerns in Pregnant Women
The study was conducted in order to determine the effect of mindfulness-based sexual counseling on sexual distress, attitude towards sexuality and body image concerns in pregnant women.
The research was planned in a randomized controlled experimental design.The sample consisted of the pregnant women who applied to the pregnant class at the time of the study and met the inclusion criteria.
Female Sexual Distress Scale-Revised, Attitude towards Sexuality in Pregnancy Scale, Body Image Concerns During Pregnancy Scale were used.
In the study, the pregnant women in the experimental group were given mindfulness-based sexual counseling by the researcher.
Mindfulness-based sexual counseling was planned as 2 sessions per week for 4 weeks, in total 8 sessions.
Each session lasted 30-40 minutes on average.
First of all, Pregnancy Introduction Form, Attitude towards Sexuality in Pregnancy Scale, Female Sexual Distress Scale-Revised and Body Image Concerns in Pregnancy Scale were applied to the pregnant women in the experimental and control groups.
The experimental group was given mindfulness-based sexual counseling for 4 weeks by the researcher.
At the end of the mindfulness-based sexual counseling, the experimental group and the control group at the same time, were applied to the experimental group and the control group at the same time, the Female Sexual Distress Scale-Revised, Attitude towards Sexuality in Pregnancy Scale, and the Body Image Worries During Pregnancy Scale.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The research was planned in a randomized controlled experimental design.The sample consisted of the pregnant women who applied to the pregnant class at the time of the study and met the inclusion criteria.
In the power analysis used to determine the sample size, the 5% error level, the 95% confidence interval at the bilateral significance level, the 80% ability to represent the universe and the sexual distress mean score of 31.3 (standard deviation 10.9) in women.
Assuming that 67 pregnant women were calculated for each group (67 experiments, 67 controls).
Pregnancy Identification Form, Female Sexual Distress Scale-Revised, Attitude towards Sexuality in Pregnancy Scale, Body Image Concerns During Pregnancy Scale were used.
In the study, the pregnant women in the experimental group were given mindfulness-based sexual counseling by the researcher.
Mindfulness-based sexual counseling was planned as 2 sessions per week for 4 weeks, in total 8 sessions.
Each session lasted 30-40 minutes on average.
First of all, Pregnancy Introduction Form, Attitude towards Sexuality in Pregnancy Scale, Female Sexual Distress Scale-Revised and Body Image Concerns in Pregnancy Scale were applied to the pregnant women in the experimental and control groups.
The experimental group was given mindfulness-based sexual counseling for 4 weeks by the researcher.
At the end of the mindfulness-based sexual counseling, the experimental group and the control group at the same time, were applied to the experimental group and the control group at the same time, the Female Sexual Distress Scale-Revised, Attitude towards Sexuality in Pregnancy Scale, and the Body Image Worries During Pregnancy Scale.
Study Type
Interventional
Enrollment (Actual)
134
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merkez
-
Malatya, Merkez, Turkey, 44000
- Faculty of Health Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Communicating,
- Over the age of 18,
- Pregnancy week between 10-28 weeks,
- Scoring 11.5 points and above according to the Female Sexual Distress Scale-Revised,
Exclusion Criteria:
- Sexual distress before pregnancy,
- Pregnant women with psychological diagnosis according to records.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MBSC group
counseling group
|
Mindfulness-based sexual counseling was planned as 2 sessions per week for 4 weeks, in total 8 sessions.
Each session lasted 30-40 minutes on average.
The sessions were carried out individually by determining the appropriate days of pregnant women in the pregnancy class.In the study, the meditation techniques of the Mindfulness Therapy constituted the backbone/framework of the psychoeducation program.
Body and breath, body scanning, mindfulness movement and three-minute respiration techniques were practiced during the psychoeducation program, practically every session in accordance with the researchers' directives.
|
|
No Intervention: Control group
standard care group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Female Sexual Distress
Time Frame: Change from Female Sexual Distress at 4 weeks
|
It is used to identify women with and without sexual dysfunction, evaluating subjective stress and psychological effects associated with sexual function.
Responses to the items in the five-point Likert scale consist of never (0), rarely (1), sometimes (2), often (3), or always (4).
The lowest score that can be obtained from the scale is 0, the highest score is 52.
Higher scores indicate higher levels of sexual distress.
|
Change from Female Sexual Distress at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Scale of Attitude towards Sexuality in Pregnancy
Time Frame: Change from Attitude towards Sexuality at 4 weeks
|
The items contain cognitive, affective and behavioral components of sexual attitude.
The scale has three sub-dimensions; "Anxiety Towards Sexual Intercourse During Pregnancy", "Beliefs and Values Towards Sexuality During Pregnancy", "Confirming Sexuality During Pregnancy".
The total score that can be obtained from the total score of the scale is the lowest 34 and the highest 170.
The increase in the total score obtained from ATSPS indicates that the attitudes towards sexuality during pregnancy are positive, and the decrease in the total score indicates that the attitudes towards sexuality during pregnancy are negative.
|
Change from Attitude towards Sexuality at 4 weeks
|
|
Body Image Worries in Pregnancy Scale
Time Frame: Change from Body Image Worries at 4 weeks
|
The scale consists of 4 sub-dimensions.
Sub-dimensions of the scale Avoidance, Social worries, Worries about weight gain, Future worries, physical appearance concerns.The highest score to be obtained from the scale is 115, the lowest score is 23.An increase in the total score of the scale indicates that concerns about body image are high during pregnancy, while a decrease indicates that concerns about body image during pregnancy are low.
|
Change from Body Image Worries at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sıdıka Özlem Cengizhan, Msc, Inonu University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nezamnia M, Iravani M, Bargard MS, Latify M. Effectiveness of cognitive-behavioral therapy on sexual function and sexual self-efficacy in pregnant women: An RCT. Int J Reprod Biomed. 2020 Aug 19;18(8):625-636. doi: 10.18502/ijrm.v13i8.7504. eCollection 2020 Aug.
- Brotto LA, Basson R, Luria M. A mindfulness-based group psychoeducational intervention targeting sexual arousal disorder in women. J Sex Med. 2008 Jul;5(7):1646-59. doi: 10.1111/j.1743-6109.2008.00850.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2020
Primary Completion (Actual)
August 25, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
May 19, 2021
First Submitted That Met QC Criteria
May 23, 2021
First Posted (Actual)
May 25, 2021
Study Record Updates
Last Update Posted (Actual)
May 25, 2021
Last Update Submitted That Met QC Criteria
May 23, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-786
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
individual participant data were not shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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