NCT05790967

Brief Summary

Aim: In this study, it is aimed to determine the effect of sexual education given to pregnant women on attitudes towards sexuality and sexual response during pregnancy. The study will be carried out in two different groups. After the women are evaluated in terms of eligibility criteria for the research, the eligible pregnant women will be informed about the research and written informed consent will be obtained from those who accept. Random distribution of pregnant women to study groups will be made using the Block Randomization method. The following applications will be made to the groups. Education Group: Women in the experimental group will be given education on sexual life during pregnancy. Before the training, preliminary data will be collected and then the participants will be given two hours of individual and face-to-face training. At the end of the training, homework will be given to pregnant women to practice at home, including "sharing their sexual feelings and thoughts with their spouse, sharing problems and concerns about sexuality during pregnancy, and using alternative ways other than sexual intercourse. In addition, a "Sexual Life in Pregnancy Information Booklet" will be given, and they will be asked to read the information in the booklet and share it with their spouses. After 4 weeks, the data sheets will be applied again. Control Group: Patients in the control group of the study will not be subjected to any treatment other than the routine procedure. Data collection forms will be applied to the patients in the control group at the beginning of the study and after 4 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

March 27, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

March 17, 2023

Last Update Submit

November 13, 2023

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (2)

  • Change in sexual response

    Pregnancy Sexual Response Inventory which evaluates sexual activity and sexuality problems in pregnant women, consists of two parts and a total of 38 items. The total score ranges from 0 to 100, with scores between 0-25 as "Very bad", between 25-50 as "Bad", between 50-75 as "Good" and between 75-100 as "Excellent".

    baseline, four weeks later

  • Attitude Scale toward Sexuality during Pregnancy Change:

    Attitude towards Sexuality in Pregnancy consists of 34 items and 3 sub-dimensions. The increase in the total score obtained from the scale 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. In addition, the cut-off point of the scale was determined as 111.5.

    baseline, four weeks later

Study Arms (2)

Education Group

EXPERIMENTAL
Other: Sexual Education

CONTROL

NO INTERVENTION

Interventions

Sexual EducationOTHER

Women in the experimental group will be given education on sexual life during pregnancy. Before the training, preliminary data will be collected and then the participants will be given two hours of individual and face-to-face training.

Education Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primigravida
  • Having a singleton pregnancy
  • Being between 14 -22 weeks of pregnancy
  • Living with their partner

You may not qualify if:

  • Pregnant woman or her partner has a previous diagnosis of sexual dysfunction
  • Having a risky situation where sexual intercourse is prohibited during pregnancy by the physician
  • Use of psychiatric drugs
  • Pregnant woman or her partner has a previous diagnosis of sexual dysfunction
  • Having a risky situation where sexual intercourse is prohibited during pregnancy by the physician
  • Use of psychiatric drugs such as antidepressants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Cebeci Hospital

Ankara, Mamak, 06620, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Faculty of Nursing

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 30, 2023

Study Start

March 27, 2023

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)