The Effect of Sexual Counselling Based on PLISSIT and BETTER Model After Hysterectomy

NCT06609096 | Completed

• 1 other identifier: 908520
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

Sexuality is affected by several physiological, cultural, social, and psychological factors. Hysterectomy is one of the factors that affects sexuality. Evidence suggests that hysterectomy, affects the sexual function of women. Therefore, this study aimed to evaluate the effect of sexual counseling based on the PLISSIT and BETTER models on sexual function and quality of sexual life of women after hysterectomy. This study is a randomized controlled trial with a three-arm parallel design. One of the experimental groups will receive sexual counseling based on the PLISSIT model and the other will receive sexual counseling based on the BETTER model. The control group will not receive any intervention. The difference between the intervention groups and the control group will be evaluated.

Conditions

Hysterectomy; PLISSIT Model; Sexual Health Quality of Life; Sexual Function; Sexual Health

Keywords

sexual health; Hysterectomy; Sexual Counseling

Outcome Measures

Primary Outcomes (2)

• Sexual Quality of Life Scale-Female Scale

  Sexual Quality of Life Scale-Female (SQOL-F) developed by Symonds et al. (2005). The scale should be completed by considering sexual life in the last four weeks. The scale consisted of 18 items and was evaluated between 1 and 6 points. As the scale score increased, so did the quality of sexual life.

  Change from baseline level sexual function to month 1 and month 2

• Female Sexual Function Scale

  The Female Sexual Function Scale (FSFI) developed by Rosen et al. (2000) focused on sexual problems in the last four weeks and evaluated sexual function. It consists of 19 questions and six sub-dimensions including desire, arousal, lubrication, orgasm, satisfaction, and pain. The scores obtained from the scale varied between 2 and 36. As the scale score increased, sexual function also increased. The cutoff score of the scale was 26.55. Those with a score of 26.55 and below were considered to have female sexual dysfunction.

  Change from baseline level sexual function to month 1 and month 2

Study Arms (3)

PLISSIT Group

EXPERIMENTAL

Women assigned to the sexual counseling group based on the PLISSIT model will receive four sessions in total, once a week. Each session consisted of an average of 30 min. Sessions will be conducted online as individual counselling sessions. The Plissit model was used based on a four-stage approach. These stages are (P-Permission): Permission, (Ll- Limited Information), providing limited information (SS-Specific Suggestions): Giving specific suggestions, (IT- Intensive Therapy): Intensive Therapy. In this study, the first three stages of the model will be applied. After the first three stages of the model are implemented, women with ongoing sexual problems are referred to specialized sexual therapists for intensive treatment/therapy.

Behavioral: Sexual counseling based on the PLISSIT model

BETTER Group

EXPERIMENTAL

Women assigned to the sexual counseling group based on the BETTER model will receive four sessions in total, once a week. Each session will consist of 30 minutes on average. Better model consists of Bring up the topic, Explain, Telling, Timing, Education and Recording steps. The sessions will be conducted online as individual counselling sessions.

Behavioral: Sexual counseling based on the BETTER model

Control Group

NO INTERVENTION

Women in the control group will not receive any intervention.

Interventions

Sexual counseling based on the PLISSIT model BEHAVIORAL

Four sessions of sexual counseling based on the PLISSIT model will be provided. The intervention consisted of four consecutive sessions, with one session per week. Each session is 30 minutes on average.

PLISSIT Group

Sexual counseling based on the BETTER model BEHAVIORAL

A total of four sessions of sexual counseling based on the BETTER model will be provided. The intervention consists of four consecutive sessions, one session per week. Each session is 30 minutes on average.

BETTER Group

Eligibility Criteria

• Gender Eligibility Details: Female participants who have had a hysterectomy operation can participate in this study.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a sexual partner
• Sexual intercourse within the last month,
• A score below 26.55 on the Female Sexual Function Scale,
• At least 3 months after the hysterectomy operation,
• No previous radiotherapy or chemotherapy treatment,
• Not having any communication problems (mental, auditory, visual, etc.),
• Not being involved in any other sexuality-related treatment program,
• Becoming literate,
• Having a smartphone,
• Access to the Internet
• Volunteering to participate in the study

You may not qualify if:

• Different treatment protocols due to malignancy (radiotherapy and chemotherapy or additional surgical treatment of the reproductive organs)

Sponsors & Collaborators

• Kutahya Health Sciences University: lead
• Gazi University: collaborator

Study Sites (2)

Gazi University Health Research And Application Center

Ankara, 06500, Turkey (Türkiye)

Location

Kütahya Health Sciences University

Kütahya, 43020, Turkey (Türkiye)

Location

Study Officials

• Sevil Çiçek Özdemir, Asst. Prof.

  Kütahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In order to prevent outcome reporting bias, the data obtained from the study will be coded as A, B and C by an independent researcher and transferred to the SPSS program. Group assignment will be concealed from the researchers during the data analysis and reporting process.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: July 23, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)