Clinical trial NCT04900194: The Effect of Mindfulness-based Sexual Counseling on Sexual Distress in Pregnant Women
Official title: The Effect of Mindfulness-based Sexual Counseling on Sexual Distress, Attitudes Towards Sexuality and Body Image Concerns in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Counseling
Keywords: pregnancy
mindfulness
sexuality
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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. In the power analysis used to determine the sample size, the 5% error level, the 95% confidence interval at the bilateral significance level, the 80% ability to represent the universe and the sexual distress mean score of 31.3 (standard deviation 10.9) in women. Assuming that 67 pregnant women were calculated for each group (67 experiments, 67 controls). Pregnancy Identification Form, 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.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

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

Primary outcomes:
measure: Female Sexual Distress
timeFrame: Change from Female Sexual Distress at 4 weeks
Secondary outcomes:
measure: The Scale of Attitude towards Sexuality in Pregnancy
timeFrame: Change from Attitude towards Sexuality at 4 weeks
measure: Body Image Worries in Pregnancy Scale
timeFrame: Change from Body Image Worries at 4 weeks
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Faculty of Health Science
state: Merkez
Study officials:
affiliation: Inonu University
name: Sıdıka Özlem Cengizhan, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.