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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05796180
Other study ID # NSIMALYAVUZ
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date December 2024

Study information

Verified date January 2024
Source Lokman Hekim Üniversitesi
Contact Nurgül SIMAL YAVUZ, Lecturer
Phone +90 554 234 8957
Email nurgulsimal@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, the investigators wanted to examine the effect of sexual health counseling to women in the postpartum period on the quality of life of the participants.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Primiparous, - Have had a vaginal birth, - Those who will live with their partner in the period after birth, - Having started sexual intercourse before starting training, - Without a diagnosed chronic disease (DM, HT, Heart disease, etc.), - 18 years or older, - Able to speak and understand Turkish, Exclusion Criteria: • Edinburgh Postpartum Depression Scale score of 12 and above,

Study Design


Related Conditions & MeSH terms

  • Health Knowledge, Attitudes, Practice
  • Sexuality

Intervention

Behavioral:
Behavioral: sexual health counseling based on the BETTER model
The content of the research will be discussed by face-to-face interviews with women who gave birth vaginally and applied to the hospital for birth control 8-10 weeks after delivery. Pre-evaluation forms will be applied to women who have agreed to participate in the study to evaluate the inclusion criteria. Women who meet the inclusion criteria will be divided into experimental-control groups using the block randomization method. An appointment will be made for interviews with the women in the experimental group. It is planned that these meetings will be held in the form of online video calls and will last an average of 45 minutes. The final tests will be held 8 weeks after the online meetings are over.

Locations

Country Name City State
Turkey Lokman Hekim Etlik Hospital Ankara Keçiören

Sponsors (1)

Lead Sponsor Collaborator
Lokman Hekim Üniversitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postpartum Sexual Life Quality Scale The scale is still under development. 8 week
Primary Arizona Sexual Experiences Scale The Arizona Sexual Experiences Scale (ASEX) is a 6-point Likert-type self-report scale and consists of 5 questions. This form reveals the capacity to reach orgasm, the feeling of satisfaction, vaginal wetness, arousal and sexual drive. Each question is scored from 1 to 6. The total score ranges from 5 to 30. Low scores indicate that the sexual response is satisfactory, strong and easy, while high scores indicate the presence of sexual dysfunction. The total scale score is formed by the sum of the scores of the scale items in the scale. The cut-off point of the scale was determined as 11. A score of 5 or more for each item indicates that there is a sexual dysfunction related to that item. 8 week
Primary VAS satisfaction scale Women's satisfaction with sexual life will be evaluated with the visual analog scale (VAS). It shows that women who score high on the scale, which is scored between 0 (very dissatisfied) and 10 (very satisfied), also have high sexual satisfaction. 8 week
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