Clinical trial NCT05805228: Sexual Life of Couples During Pregnancy and Postpartum Period
Official title: The Effect of Sexual Counseling on the Sexual Lives of Couples During Pregnancy and Postpartum Period.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Postpartum Sexual Dysfunction
Sexual Dysfunction
Keywords: sexual counseling
pregnancy
postpartum
Information-motivation-behavioral model
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 202
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study was conducted with experimental and control group design.
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline In Sexual Function On The Pregnant Women's Female Sexual Function Index (FSFI) Score Averages at 8 Months
timeFrame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
measure: 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
timeFrame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
measure: Change From Baseline In Sexual Satisfaction On The Pregnant Women's The New Sexual Satisfaction Scale Score Averages at 8 Months
timeFrame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
measure: Change From Baseline In Sexual Satisfaction On The Men With a Pregnant Wife The New Sexual Satisfaction Scale Score Averages at 8 Months
timeFrame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
Secondary outcomes:
measure: Change From Baseline In Depression Symptom Levels On The Pregnant Women The Center for Epidemiological Studies-Depression Scale Score Averages at 8 Months
timeFrame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
measure: 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
timeFrame: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: istanbul university Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: ceyda esen
role: PRINCIPAL_INVESTIGATOR
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