Sexual Life of Couples During Pregnancy and Postpartum Period

NCT05805228 | Completed DMC

• 1 other identifier: ceydaes
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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. 1.Does sexual counseling to be conducted during pregnancy prevent the problems that may occur in women during pregnancy and postpartum period?
2. 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.

Conditions

Pregnancy Related; Postpartum Sexual Dysfunction; Sexual Dysfunction

Keywords

sexual counseling; pregnancy; postpartum; Information-motivation-behavioral model

Outcome Measures

Primary Outcomes (4)

• 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)

  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

  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

  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

  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 Outcomes (2)

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

  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

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Only routine antenatal and postnatal care was given to the couples in the control group

Interventions

Sexual Counseling OTHER

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

Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

istanbul university Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (28)

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  PMID: 34278195 BACKGROUND

• 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.

  BACKGROUND

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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

  BACKGROUND

• 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.

  PMID: 35372614 BACKGROUND

• 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.

  PMID: 23734860 BACKGROUND

• 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.

  PMID: 34536325 BACKGROUND

• 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.

  PMID: 30388952 BACKGROUND

• Dancet EAF, D'Hooghe TM, Dreischor F, van Wely M, Laan ETM, Lambalk CB, Repping S, Custers IM. The 'Pleasure&Pregnancy' web-based interactive educational programme versus expectant management in the treatment of unexplained subfertility: protocol for a randomised controlled trial. BMJ Open. 2019 Jul 9;9(7):e025845. doi: 10.1136/bmjopen-2018-025845.

  PMID: 31289062 BACKGROUND

• Dabiri F, Yabandeh AP, Shahi A, Kamjoo A, Teshnizi SH. The effect of mode of delivery on postpartum sexual functioning in primiparous women. Oman Med J. 2014 Jul;29(4):276-9. doi: 10.5001/omj.2014.72.

  PMID: 25170409 BACKGROUND

• Dagli E, Kul Uctu A, Ozerdogan N. Sexual dysfunction in the postpartum period: Its relationship with postpartum depression and certain other factors. Perspect Psychiatr Care. 2021 Apr;57(2):604-609. doi: 10.1111/ppc.12583. Epub 2020 Jul 17.

  PMID: 32677049 BACKGROUND

• Dawson SJ, Leonhardt ND, Impett EA, Rosen NO. Associations Between Postpartum Depressive Symptoms and Couples' Sexual Function and Sexual Distress Trajectories Across the Transition to Parenthood. Ann Behav Med. 2021 Aug 23;55(9):879-891. doi: 10.1093/abm/kaaa117.

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• Evcili F, Demirel G, Bekar M, Guler H. Effectiveness of postpartum sexual health education programme structured according to Levine's conservation model: An interventional study. Int J Nurs Pract. 2020 Jun;26(3):e12855. doi: 10.1111/ijn.12855. Epub 2020 Jun 8.

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• Gutzeit O, Levy G, Lowenstein L. Postpartum Female Sexual Function: Risk Factors for Postpartum Sexual Dysfunction. Sex Med. 2020 Mar;8(1):8-13. doi: 10.1016/j.esxm.2019.10.005. Epub 2019 Dec 16.

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• Heidari M, Aminshokravi F, Zayeri F, Azin SA. Effect of Sexual Education on Sexual Function of Iranian Couples During Pregnancy: A Quasi Experimental Study. J Reprod Infertil. 2018 Jan-Mar;19(1):39-48.

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• Jacob L, Smith L, Butler L, Barnett Y, Grabovac I, McDermott D, Armstrong N, Yakkundi A, Tully MA. Challenges in the Practice of Sexual Medicine in the Time of COVID-19 in the United Kingdom. J Sex Med. 2020 Jul;17(7):1229-1236. doi: 10.1016/j.jsxm.2020.05.001. Epub 2020 May 14.

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• John SA, Walsh JL, Weinhardt LS. The Information-Motivation-Behavioral Skills Model Revisited: A Network-Perspective Structural Equation Model Within a Public Sexually Transmitted Infection Clinic Sample of Hazardous Alcohol Users. AIDS Behav. 2017 Apr;21(4):1208-1218. doi: 10.1007/s10461-016-1446-2.

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• Afshar M, Mohammad-Alizadeh-Charandabi S, Merghti-Khoei ES, Yavarikia P. The effect of sex education on the sexual function of women in the first half of pregnancy: a randomized controlled trial. J Caring Sci. 2012 Nov 22;1(4):173-81. doi: 10.5681/jcs.2012.025. eCollection 2012 Dec.

  PMID: 25276693 RESULT

• Barrett G, Pendry E, Peacock J, Victor C, Thakar R, Manyonda I. Women's sexual health after childbirth. BJOG. 2000 Feb;107(2):186-95. doi: 10.1111/j.1471-0528.2000.tb11689.x.

  PMID: 10688502 RESULT

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Sex Counseling

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sexology; Behavioral Sciences; Behavioral Disciplines and Activities; Counseling; Mental Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• ceyda esen

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Model Details: This study was conducted with experimental and control group design.

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 7, 2023
• Study Start: December 15, 2020
• Primary Completion: March 25, 2021
• Study Completion: February 20, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)