Sexual Life of Couples During Pregnancy and Postpartum Period

April 6, 2023 updated by: Ceyda Esen, Istanbul University - Cerrahpasa (IUC)

The Effect of Sexual Counseling on the Sexual Lives of Couples During Pregnancy and Postpartum Period.

The aim of this clinical trials is to determine the effect of sexual counseling applied in line with a special counseling model on the sexual functions of couples during pregnancy and postpartum period in order to prevent sexual problems that may occur in the pregnant woman and her husband during pregnancy.

The main questions it aims to answer are:

  1. Does sexual counseling to be conducted during pregnancy prevent the problems that may occur in women during pregnancy and postpartum period?
  2. Does sexual counseling to be conducted during pregnancy prevent the problems that may occur in pregnant women's husband during pregnancy and postpartum period? Questionnaires evaluating the sexual lives of the participants were administered. Afterwards, sexual counseling was given to the pregnant woman and her husband in the first three months of pregnancy. After the counseling, the questionnaires were applied again in the later stages of pregnancy and in the postpartum period. In order to see whether sexual counseling affects sexual problems that may develop during pregnancy and postpartum period, the researchers compared the counseling couples with the pregnant women who did not receive counseling and their spouses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before starting the research, the researcher participated in the Sex Therapy Education Certificate Program to better research and educate pregnant women and their spouses. After she completed the certificate program, necessary permissions were obtained from the related institution. Verbal and written consent was obtained from the couples who came to the outpatient clinic for routine pregnancy monitoring at ten-fourteen weeks of pregnancy. The couples were interviewed through face-to-face interview method by applying the information form and scales in an appropriate environment that allows for privacy. Couples who met the criteria after pre-evaluation were included in the study. The separation of the groups was made by the medical secretary of the outpatient clinic, who was unrelated to the study, using a pre-coded list according to the order of arrival of the couples. Participants were divided into two groups as experimental and control. An appointment was made for the couples in the experimental group for an interview at a time convenient for them and in a suitable environment in the hospital. In accordance with IMB Model stages, a counseling for sexual health of the couples was planned and provided. The couples in the experimental group were given routine prenatal and postnatal care with sexual counseling. Only routine antenatal and postnatal care was given to the couples in the control group . The scales were applied to both groups four times in total, and repeated measurements were made. The scales were applied to both groups 4 times in total, in the first, second, third trimesters of pregnancy and in the 3rd month postpartum, and repeated measurements were made. All the scales after the first measurement were obtained by filling in the forms of the couples online. The couples in the experimental group were called by phone between each measurement and a total of three online interviews were made.

Sexual Counseling Process The sexual counseling program was applied to the couples in the experimental group in two sessions. The "Sexual Counseling I" session which includes information about sexual life specific to the pregnancy period, was conducted at least one week later the pre-test, with face-to-face interview method in a private room in the pregnancy outpatient clinic. The "Sexual Counseling II" session, which contains information on sexual life specific to the postpartum period, was conducted online in the third trimester of pregnancy with the video interview method. Counseling sessions consisted of power point presentations (including figures and drawings) and counseling booklet. The counseling booklet prepared by the researcher in accordance with literature consisted of two parts; sexual life during pregnancy and postpartum sexual life. Each session lasted forty-five minutes and additional time was allocated for answering the questions. After the counseling, the counseling booklets were given to the couples online. In addition, they were given a contact number where they could contact the consultant and ask questions, and they were contacted during the study.

Study Type

Interventional

Enrollment (Actual)

202

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

  • Turkey
      • Istanbul, Turkey, 34000
        • İstanbul University Cerrahpaşa

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primigravid pregnant women at 10-14 weeks of gestation and their spouses
  • Pregnant women and their spouses with FSFI Scale score ≤26.55
  • Couples with regular sex life

Exclusion Criteria:

  • Having a high-risk pregnancy
  • Being pregnant with infertility treatment
  • The couples had a history of medical illness.

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
The sexual counseling program was applied to the couples in the experimental group in 2 sessions. The "Sexual Counseling I" session which includes information about sexual life specific to the pregnancy period, was conducted at least one week later the pre-test, with face-to-face interview method in a private room in the pregnancy outpatient clinic. The "Sexual Counseling II" session, which contains information on sexual life specific to the postpartum period, was conducted online in the third trimester of pregnancy with the video interview method. Counseling sessions consisted of power point presentations (including figures and drawings) and counseling booklet. The counseling booklet prepared by the researcher in accordance with literature consisted of two parts; sexual life during pregnancy and postpartum sexual life. Each session lasted 45 minutes and additional time was allocated for answering the questions.
Other: Sexual Counseling
Pregnancy and postpartum period-specific sexual counseling was given to pregnant women and their spouses.
No Intervention: Control Group
Only routine antenatal and postnatal care was given to the couples in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline In Sexual Function On The Pregnant Women's Female Sexual Function Index (FSFI) Score Averages at 8 Months
Time Frame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
FSFI is a validated. This index has nineteen items about sexual functioning of the patients during the last one month. High scores signify positive assessments. Total score of the scale ranges between two and thirty-six points. The scale's cutoff point is 26.55 and getting a score of 26.55 is considered to have sexual dysfunction. Change= baseline (14th week of pregnancy)-12 week after first measurement (28th week of pregnancy)- 8 week after second measurement (36th of week of pregnancy)- 12 week after third measurement (3rd month after delivery)
baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
Change From Baseline In Sexual function On The Men With a Pregnant Wife On The Arizona Sexual Experiences Scale (ASEX) Score Averages of at 8 Months
Time Frame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
This scale is a validated. This scale was developed to reveal and evaluate sexual functions and disorders in sexual functions. In the scale, each of the sexual functions in the last week is questioned with a question. It has 5 sub-scales: sexual desire, erection, orgasm and satisfaction. Each of the questions is scored between 1-6 points. The total scale score varies between 5 points and 30 points. High scores signify a low degree of sexual function. Change= baseline (14th week of pregnancy)-12 week after first measurement (28th week of pregnancy)- 8 week after second measurement (36th of week of pregnancy)- 12 week after third measurement (3rd month after delivery)
baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
Change From Baseline In Sexual Satisfaction On The Pregnant Women's The New Sexual Satisfaction Scale Score Averages at 8 Months
Time Frame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
This scale is a validated. These are the results of evaluating the sexual satisfactions of pregnant women. There are 20 items in the scale that can be scored between 1 and 5. The lowest score that can be obtained from the scale is 20, and the highest score is 100. The total scoring of the scale is calculated by summing the items. As the total score of the scale increases, the sexual satisfaction of the individual also increases. Change= baseline (14th week of pregnancy)-12 week after first measurement (28th week of pregnancy)- 8 week after second measurement (36th of week of pregnancy)- 12 week after third measurement (3rd month after delivery)
baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
Change From Baseline In Sexual Satisfaction On The Men With a Pregnant Wife The New Sexual Satisfaction Scale Score Averages at 8 Months
Time Frame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
This scale is a validated. These are the results of evaluating the sexual satisfactions of pregnant women's husband. There are 20 items in the scale that can be scored between 1 and 5. The lowest score that can be obtained from the scale is 20, and the highest score is 100. The total scoring of the scale is calculated by summing the items. As the total score of the scale increases, the sexual satisfaction of the individual also increases. Change= baseline (14th week of pregnancy)-12 week after first measurement (28th week of pregnancy)- 8 week after second measurement (36th of week of pregnancy)- 12 week after third measurement (3rd month after delivery)
baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline In Depression Symptom Levels On The Pregnant Women The Center for Epidemiological Studies-Depression Scale Score Averages at 8 Months
Time Frame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
This scale is a validated. The scale evaluates depressive symptoms and other variables that affect it. There are 20 items in the scale, each scored between 0-3 points. The scale questions the past week. The total score of the scale varies between 0-60 points. A score of 16 and above suggests the presence of depression. Change= baseline (14th week of pregnancy)-12 week after first measurement (28th week of pregnancy)- 8 week after second measurement (36th of week of pregnancy)- 12 week after third measurement (3rd month after delivery)
baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
Change From Baseline In Depression Symptom Levels On The Men With a Pregnant Wife The Center for Epidemiological Studies-Depression Scale Score Averages at 8 Months
Time Frame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
This scale is a validated. The scale evaluates depressive symptoms and other variables that affect it. There are 20 items in the scale, each scored between 0-3 points. The scale questions the past week. The total score of the scale varies between 0-60 points. A score of 16 and above suggests the presence of depression. Change= baseline (14th week of pregnancy)-12 week after first measurement (28th week of pregnancy)- 8 week after second measurement (36th of week of pregnancy)- 12 week after third measurement (3rd month after delivery)
baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: ceyda esen, Istanbul University - Cerrahpasa (IUC)

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

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)

December 15, 2020

Primary Completion (Actual)

March 25, 2021

Study Completion (Actual)

February 20, 2022

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ceydaes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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