NCT05646537

Brief Summary

The aim of this study is to examine the effect of NLP techniques on stoma compliance and quality of life in patients with stoma. The study will be conducted using a prospective randomized controlled single-blind clinical trial model. The research will consist of patients with temporary or permanent colostomy/ileostomy, who are hospitalized in Mersin City Training and Research Hospital. Research data will be obtained with demographic questionnaire, Adjustment Scale for Individuals with Ostomy and Stoma Quality of Life Scale. Analysis of the study data will be done through the IBM SPSS Statistics 26 package program. While evaluating the study data, frequencies (number, percentage) for categorical variables and descriptive statistics (mean, standard deviation) for numerical variables will be given. Statistical significance in the analyzes will be interpreted at the 0.05 level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

November 10, 2022

Last Update Submit

April 7, 2025

Conditions

Keywords

NurseNLPpainCesareannonpharmacologicalholistic carepostpartumperianesthesia processsurgery

Outcome Measures

Primary Outcomes (1)

  • stoma compliance scores of the participants

    At the end of the firsth day to measure the comfort level of the participants, the average score of the Individual with a postpartum comfort Scale will be calculated The General Comfort Questionnaire developed by Kolcaba (1992). Designed as a five-point Likert-type scale, the PCS has 34 items. In this respect, the participants respond to PCS items by rating them from 1 point to 5 points. In positively worded items, "I strongly agree" refers to the highest level of comfort whilst "I strongly disagree" points to the lowest level of comfort. Negatively worded items were reverse-coded. The minimum and maximum scores to be obtained from the PCS are successively 34 and 170 points. There is no cut-off point for the PCS. As the scores obtained from the PCS increase, the comfort levels also go up. Cronbach's alpha coefficient as the measure of internal consistency was found as 0.78 for the PCS

    1th day

Secondary Outcomes (1)

  • comfort level of the participants

    3th day

Study Arms (2)

The group to which NLP techniques will be applied

EXPERIMENTAL

After the participant consented to participate in the study with the Informed Consent Form, her comfort level was measured with the Postpartum Comfort Scale. A session of NLP (30 minutes) was applied to the participant. The patient was informed about the application. The mother was asked to sit or lie down i Before the discharge of the participant from the hospital, her comfort level was evaluated once again by using the Postpartum Comfort Scale

Behavioral: Neuro-Linguistic Programming Techniques

Control group

NO INTERVENTION

After the participant consented to participate in the study with the Informed Consent Form, her comfort level was measured with the Postpartum Comfort Scale. Without having any additional practice, the participant solely had the routine clinical protocol. Before the discharge of the participant from the hospital, her comfort level was evaluated once again by using the Postpartum Comfort Scale.

Interventions

The new behavior creation technique of NLP is based on the argument that the imagination process and reality are recorded in the same way in the brain. Using the Participant's eye movements and imagination . He will be asked to imagine himself while caring for the stoma. participient will then be asked to re-enact the process with the correct stages of stoma care and the jurals that must be adhered to in order to successfully care for it. Questions will be asked about where he can find the support he needs to carry out this process successfully. At the end of this whole process, he will be expected to construct what life is like with a stoma.The technique will be applied to the patient once and will be instructed to remember this successful process every time he or she feels distressed about the stoma. At the end of 6 months, the quality of life and compliance will be evaluated by asking the scale questions again.

The group to which NLP techniques will be applied

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailswoman
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having a c-section for the first time, being within the period after a minimum of 6 hours and before a maximum of 24 hours following the c-section,
  • agreeing to participate in the study,
  • not using patient-controlled analgesics, not having an additional health problem, except the c-section incision, which will likely lead to pain in the postpartum period,
  • speaking and understanding Turkish, having no disability limiting mobility

You may not qualify if:

  • Mothers who wanted to withdraw from the research in any stage after being included in the sample,
  • who could not have verbal communication,
  • who had a hearing or visual problem, and who were previously diagnosed with a psychiatric disease were excluded from the research sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toros University

Mersin, Mersin, 33140, Turkey (Türkiye)

Location

Related Publications (1)

  • Dogan A, Dal NA, Beydag KD. Effect of neuro-linguistic programming on comfort after cesarean: a randomized controlled trial neuro-linguistic programming comfort level cesarean. BMC Pregnancy Childbirth. 2025 Aug 30;25(1):902. doi: 10.1186/s12884-025-08043-8.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know they are in the experimental or control group
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: NLP techniques will be applied to the experimental group, and no intervention will be applied to the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

November 10, 2022

First Posted

December 12, 2022

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

One year after the study results were published in a scientific journal

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
48th months
Access Criteria
With the permission of the principal investigator

Locations