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AzTrials

Pregnancy RelatedNCT05805228

Sexual Life of Couples During Pregnancy and Postpartum Period

A study testing Sexual Counseling in people with Pregnancy Related and Postpartum Sexual Dysfunction, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Sexual Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2020to 20 Feb 2022
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • istanbul university Cerrahpasa

    Istanbul, 34000

Other trials in Turkey (Türkiye)

About this study

Official title: 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.
Read the 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.

Being tested
Sexual Counseling
Keywords
sexual counseling, pregnancy, postpartum, Information-motivation-behavioral model
Medical subject headings
Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sexual CounselingOther

    Pregnancy and postpartum period-specific sexual counseling was given to pregnant women and their spouses.

Study groups in NCT05805228
Study groupRoleWhat they receive
Experimental GroupExperimentalThe 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.
Receives: Other: Sexual Counseling
Control GroupNo interventionOnly routine antenatal and postnatal care was given to the couples in the control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline In Sexual Function On The Pregnant Women's Female Sexual Function Index (FSFI) Score Averages at 8 Months

    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)

    Measured: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement

  2. 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

    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)

    Measured: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement

  3. Change From Baseline In Sexual Satisfaction On The Pregnant Women's The New Sexual Satisfaction Scale Score Averages at 8 Months

    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)

    Measured: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement

  4. Change From Baseline In Sexual Satisfaction On The Men With a Pregnant Wife The New Sexual Satisfaction Scale Score Averages at 8 Months

    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)

    Measured: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement

Secondary outcomes (2)

  1. Change From Baseline In Depression Symptom Levels On The Pregnant Women The Center for Epidemiological Studies-Depression Scale Score Averages at 8 Months

    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)

    Measured: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement

  2. 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

    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)

    Measured: baseline, 12 week after baseline, 8 week after second measurement and 12 week after third measurement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2023
  2. Study start15 Dec 2020
  3. Primary completion25 Mar 2021
  4. Study completion20 Feb 2022

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
This study was conducted with experimental and control group design.
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05805228
Sponsor's protocol ID
ceydaes
Status last verified
Apr 2023
First submitted
28 Feb 2023
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alidost F, Pakzad R, Dolatian M, Abdi F. Sexual dysfunction among women of reproductive age: A systematic review and meta-analysis. Int J Reprod Biomed. 2021 Jun 23;19(5):421-432. doi: 10.18502/ijrm.v19i5.9251. eCollection 2021 May.

    PubMed 34278195

  • Alidost, F., Dolatian, M., Shams, J., Nasiri, M., Reisabdollahi, H., Pakzad, M.,ve diğ., 2021(b), The Relationship Between The Wealth Index And Pregnancy-Related Anxiety In Each Trimester Of Pregnancy And Their Effect On Sexual Dysfunction, Bangladesh Journal of Medical Science, 20, 401-408.

  • Alizadeh S, Riazi H, Majd HA, Ozgoli G. The effect of sexual health education on sexual activity, sexual quality of life, and sexual violence in pregnancy: a prospective randomized controlled trial. BMC Pregnancy Childbirth. 2021 Apr 26;21(1):334. doi: 10.1186/s12884-021-03803-8.

    PubMed 33902468

  • Allen L, Fountain L. Addressing sexuality and pregnancy in childbirth education classes. J Perinat Educ. 2007 Winter;16(1):32-6. doi: 10.1624/105812407X171076.

    PubMed 18408809

  • Allsop DB, Leavitt CE, Yorgason JB, Holmes EK. Variable Sexual Satisfaction in Pregnancy: A Latent Profile Analysis of Pregnant Wives and Their Husbands. J Sex Res. 2022 Feb;59(2):173-184. doi: 10.1080/00224499.2021.1970708. Epub 2021 Sep 14.

    PubMed 34520286

  • Aslan G, Aslan D, Kizilyar A, Ispahi C, Esen A. A prospective analysis of sexual functions during pregnancy. Int J Impot Res. 2005 Mar-Apr;17(2):154-7. doi: 10.1038/sj.ijir.3901288.

    PubMed 15538394

  • Bahadoran P, MohammadiMahdiabadzade M, Nasiri H, GholamiDehaghi A. The effect of face-to-face or group education during pregnancy on sexual function of couples in Isfahan. Iran J Nurs Midwifery Res. 2015 Sep-Oct;20(5):582-7. doi: 10.4103/1735-9066.164512.

    PubMed 26457096

  • Bahrami Z, Zarani F. Application of the Information-Motivation and Behavioral Skills (IMB) model in risky sexual behaviors amongst male students. J Infect Public Health. 2015 Mar-Apr;8(2):207-13. doi: 10.1016/j.jiph.2014.09.005. Epub 2014 Nov 22.

    PubMed 25466597

  • Bakir E, Cavusoglu H, Mengen E. Effects of the Information-Motivation-Behavioral Skills Model on Metabolic Control of Adolescents with Type 1 Diabetes in Turkey: Randomized Controlled Study. J Pediatr Nurs. 2021 May-Jun;58:e19-e27. doi: 10.1016/j.pedn.2020.11.019. Epub 2020 Dec 25.

    PubMed 33371976

  • Baksu B, Davas I, Agar E, Akyol A, Varolan A. The effect of mode of delivery on postpartum sexual functioning in primiparous women. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Apr;18(4):401-6. doi: 10.1007/s00192-006-0156-0. Epub 2006 Jul 27.

    PubMed 16871432

  • Behzadipour, S., Daneshpour, M., Damreihani, N., Aflatooni, L., 2021, Sexual satisfaction and intimacy during pregnancy and after childbirth, Sexologies, 30,2, e111-e117.

  • Bokaie M, Gashiri MZ, Khoshbin A, Salimi H. The effectiveness of sexual health counseling based on cognitive-behavioral therapy on sexual satisfaction and inefficient sexual beliefs of primigravida women. J Educ Health Promot. 2022 Feb 26;11:67. doi: 10.4103/jehp.jehp_521_20. eCollection 2022.

    PubMed 35372614

  • Cai Y, Ye X, Shi R, Xu G, Shen L, Ren J, Huang H. Predictors of consistent condom use based on the Information-Motivation-Behavior Skill (IMB) model among senior high school students in three coastal cities in China. BMC Infect Dis. 2013 Jun 4;13:262. doi: 10.1186/1471-2334-13-262.

    PubMed 23734860

  • Cattani L, De Maeyer L, Verbakel JY, Bosteels J, Deprest J. Predictors for sexual dysfunction in the first year postpartum: A systematic review and meta-analysis. BJOG. 2022 Jun;129(7):1017-1028. doi: 10.1111/1471-0528.16934. Epub 2021 Oct 17.

    PubMed 34536325

  • Chapa HO, Fish JT, Hagar C, Wilson T. Prevalence of female sexual dysfunction among women attending college presenting for gynecological care at a university student health center. J Am Coll Health. 2020 Jan;68(1):52-60. doi: 10.1080/07448481.2018.1515751. Epub 2018 Nov 2.

    PubMed 30388952

Questions about this trial

What is this clinical trial studying?

A study testing Sexual Counseling in people with Pregnancy Related and Postpartum Sexual Dysfunction, run by Istanbul University - Cerrahpasa 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 3 inclusion and 3 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 7 Apr 2023. 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?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05805228, which also lists 28 linked publications.

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 7 Apr 2023.

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