NCT05661630

Brief Summary

In this study, it was aimed to determine the effect of sexual counseling given to women with stoma with the Ex-PLISSIT model on their sexual life quality and sexual satisfaction. H1: Female patients with permanent stoma who were given sexual counseling with the EX-PLISSIT model had a higher quality of life score measured by the Sexual Quality of Life scale. H2: Female patients with permanent stoma who were given sexual counseling with the EX-PLISSIT model had higher mean scores of sexual satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

First Submitted

Initial submission to the registry

December 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2024

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

December 14, 2022

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Sexual Life Quality

    The scale is easy to apply, 6-point Likert type, which individuals can answer on their own, and consists of 18 items. Each item is expected to be answered considering the sexual life in the last four weeks. Each item of the scale is scored between 1 and 6. The items of the scale are scored as "I totally agree"=1, "I strongly agree"=2, "I partially agree"=3, "I partially disagree"=4, "I strongly disagree"=5, "I strongly disagree"=6 and 1 Questions 5, 9, 13 and 18 are reverse coded. The range of points that can be obtained from the scale is between 18-108.

    at the beginning of the study, 1 month later and 3 months later

  • Change in sexual satisfaction

    VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.

    at the beginning of the study, 1 month later and 3 months later

  • Change in satisfaction with marital relationship

    VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.

    at the beginning of the study, 1 month later and 3 months later

Study Arms (2)

EX-PLISSIT

EXPERIMENTAL
Other: COUNSELING WITH EX-PLISSIT MODEL

CONTROL

NO INTERVENTION

Interventions

In addition to the routine procedure, the women in the experimental group of the research will be given sexual counseling with the EX-PLISSIT model. The steps to be followed in accordance with this model are as follows; Session 1 Permission Limited Information The Specific Suggestions The IT-Intensive Therapy Session 2 At the beginning of the interview, the data forms will be reapplied, and then the homework given in the first session will be discussed. The information that the patient needs in line with his questions will be given within the steps of the Ex-PLISSIT model, within the steps of allowing, limited information, special recommendations and, if necessary, intensive therapy. Session 3 At the beginning of the interview, the data forms will be applied for the last time and the patient's questions, if any, will be answered and the session will be ended.

EX-PLISSIT

Eligibility Criteria

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

You may qualify if:

  • Permanent stoma for at least 6 months
  • Not receiving active surgical treatment, chemotherapy and radiotherapy (at least 6 previous treatments have been completed)
  • Married
  • Agreeing to participate in the research and obtaining written permission,

You may not qualify if:

  • Using antidepressants or using sedatives
  • Having a diagnosed psychiatric problem,
  • Do not complete the study,
  • Surgical treatment, radiotherapy or chemotherapy started due to an urgent necessity during the working process, Patients who die during the study will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University İbni Sina Hospital

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

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

December 14, 2022

First Posted

December 22, 2022

Study Start

September 4, 2023

Primary Completion

April 25, 2024

Study Completion

April 25, 2024

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations