NCT04900194

Brief Summary

The study was conducted in order to determine the effect of mindfulness-based sexual counseling on sexual distress, attitude towards sexuality and body image concerns in pregnant women. The research was planned in a randomized controlled experimental design.The sample consisted of the pregnant women who applied to the pregnant class at the time of the study and met the inclusion criteria. Female Sexual Distress Scale-Revised, Attitude towards Sexuality in Pregnancy Scale, Body Image Concerns During Pregnancy Scale were used. In the study, the pregnant women in the experimental group were given mindfulness-based sexual counseling by the researcher. Mindfulness-based sexual counseling was planned as 2 sessions per week for 4 weeks, in total 8 sessions. Each session lasted 30-40 minutes on average. First of all, Pregnancy Introduction Form, Attitude towards Sexuality in Pregnancy Scale, Female Sexual Distress Scale-Revised and Body Image Concerns in Pregnancy Scale were applied to the pregnant women in the experimental and control groups. The experimental group was given mindfulness-based sexual counseling for 4 weeks by the researcher. At the end of the mindfulness-based sexual counseling, the experimental group and the control group at the same time, were applied to the experimental group and the control group at the same time, the Female Sexual Distress Scale-Revised, Attitude towards Sexuality in Pregnancy Scale, and the Body Image Worries During Pregnancy Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 21, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

4 days

First QC Date

May 19, 2021

Last Update Submit

May 23, 2021

Conditions

Keywords

pregnancymindfulnesssexuality

Outcome Measures

Primary Outcomes (1)

  • Female Sexual Distress

    It is used to identify women with and without sexual dysfunction, evaluating subjective stress and psychological effects associated with sexual function. Responses to the items in the five-point Likert scale consist of never (0), rarely (1), sometimes (2), often (3), or always (4). The lowest score that can be obtained from the scale is 0, the highest score is 52. Higher scores indicate higher levels of sexual distress.

    Change from Female Sexual Distress at 4 weeks

Secondary Outcomes (2)

  • The Scale of Attitude towards Sexuality in Pregnancy

    Change from Attitude towards Sexuality at 4 weeks

  • Body Image Worries in Pregnancy Scale

    Change from Body Image Worries at 4 weeks

Study Arms (2)

MBSC group

EXPERIMENTAL

counseling group

Behavioral: mindfulness-based sexual counseling

Control group

NO INTERVENTION

standard care group

Interventions

Mindfulness-based sexual counseling was planned as 2 sessions per week for 4 weeks, in total 8 sessions. Each session lasted 30-40 minutes on average. The sessions were carried out individually by determining the appropriate days of pregnant women in the pregnancy class.In the study, the meditation techniques of the Mindfulness Therapy constituted the backbone/framework of the psychoeducation program. Body and breath, body scanning, mindfulness movement and three-minute respiration techniques were practiced during the psychoeducation program, practically every session in accordance with the researchers' directives.

MBSC group

Eligibility Criteria

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

You may qualify if:

  • Communicating,
  • Over the age of 18,
  • Pregnancy week between 10-28 weeks,
  • Scoring 11.5 points and above according to the Female Sexual Distress Scale-Revised,

You may not qualify if:

  • Sexual distress before pregnancy,
  • Pregnant women with psychological diagnosis according to records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Science

Malatya, Merkez, 44000, Turkey (Türkiye)

Location

Related Publications (3)

  • Nezamnia M, Iravani M, Bargard MS, Latify M. Effectiveness of cognitive-behavioral therapy on sexual function and sexual self-efficacy in pregnant women: An RCT. Int J Reprod Biomed. 2020 Aug 19;18(8):625-636. doi: 10.18502/ijrm.v13i8.7504. eCollection 2020 Aug.

  • Brotto LA, Basson R, Luria M. A mindfulness-based group psychoeducational intervention targeting sexual arousal disorder in women. J Sex Med. 2008 Jul;5(7):1646-59. doi: 10.1111/j.1743-6109.2008.00850.x.

  • Cengizhan SO, Ucar T. The Effect of Mindfulness-Based Sexual Counseling on Sexual Distress, Attitude Toward Sexuality, and Body Image Concerns in Pregnant Women: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Sep-Oct;68(5):611-618. doi: 10.1111/jmwh.13518. Epub 2023 Jun 9.

MeSH Terms

Conditions

Sexuality

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Sıdıka Özlem Cengizhan, Msc

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 25, 2021

Study Start

August 21, 2020

Primary Completion

August 25, 2020

Study Completion

December 30, 2020

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

individual participant data were not shared

Locations