Cesarean Neuro Linguistic Programming Comfort

NCT ID: NCT05646537

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Stomas are formed in order to provide stool output after surgery in cases that require removal of the bowel due to disease or trauma (Harputlu \& Özsoy, 2016). Stoma surgery is a vital surgical intervention. However, the individual may have to cope with many problems that may negatively affect the adaptation process and quality of life in terms of living with a stoma. The literature is that despite the developing stoma products and professional nurse educators, the problems related to stoma compliance and quality of life of the patients continue, and complications affecting coping with these processes are seen at different rates.

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 study 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.

The normality assumptions of the numerical variables according to the groups were examined with the Kolmogorov Smirnov test of normality and it was observed that the variables were normally distributed. For this reason, parametric statistical methods will be used in the study.

Relationships between two independent categorical variables were interpreted by Chi-square analysis. The differences between the two independent groups were examined using the Independent Sample T Test. The differences between the two dependent numerical variables will be examined with Dependent Sample T. Statistical significance in the analyzes will be interpreted at the 0.05 level.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Section Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

NLP techniques will be applied to the experimental group, and no intervention will be applied to the control group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants will not know they are in the experimental or control group

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The group to which NLP techniques will be applied

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

Group Type EXPERIMENTAL

Neuro-Linguistic Programming Techniques

Intervention Type BEHAVIORAL

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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neuro-Linguistic Programming Techniques

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Toros University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aysel DOĞAN

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Toros University

Mersin, Mersin, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40885918 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TorosUn

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.