Cesarean Section ComplicationsNCT05646537
Cesarean Neuro Linguistic Programming Comfort
A study testing Neuro-Linguistic Programming Techniques in people with Cesarean Section Complications, run by Toros University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Neuro-Linguistic Programming Techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neuro-Linguistic Programming on Comfort Level After Cesarean: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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
- Cesarean Section Complications
- Being tested
- Neuro-Linguistic Programming Techniques
- Keywords
- Nurse, NLP, pain, Cesarean, nonpharmacological, holistic care, postpartum, perianesthesia process, surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-Linguistic Programming TechniquesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1th day
Secondary outcomes (1)
comfort level of the participants
At the end of the 3th 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
Measured: 3th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jan 2023
- Primary completion1 Jul 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- NLP techniques will be applied to the experimental group, and no intervention will be applied to the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysel DOĞAN, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646537
- Sponsor's protocol ID
- TorosUn
- Status last verified
- Apr 2025
- First submitted
- 10 Nov 2022
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: One year after the study results were published in a scientific journal
Publications
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.
PubMed 40885918
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuro-Linguistic Programming on Comfort Level After Cesarean: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05646537
- Acronym / sponsor ID
- TorosUn
- Conditions
- Cesarean Section Complications
- Keywords
- Nurse, NLP, pain, Cesarean, nonpharmacological, holistic care, postpartum, perianesthesia process
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- NLP techniques will be applied to the experimental group, and no intervention will be applied to the control group.
| Arm | Type | Receives |
|---|---|---|
| The group to which NLP techniques will be applied | Experimental | Behavioral: Neuro-Linguistic Programming TechniquesAfter 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 |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro-Linguistic Programming TechniquesThe 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. | Behavioural | The group to which NLP techniques will be applied |
Primary outcome
stoma compliance scores of the participants
Time frame: 1th day
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
1 secondary outcome
comfort level of the participants
Time frame: 3th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 40885918Dogan 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.
- Individual participant dataSharing planned: Yes. One year after the study results were published in a scientific journal
Related trials for Cesarean Section Complications
Not yet recruitingObservational study
Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
Cesarean Section (MeSH: D002585), Anesthesia
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruiting
LI4 and SP6 Acupuncture for Pain After Cesarean Delivery
Acute Postoperative Pain After Cesarean Delivery
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
Recruiting
Effects of Music Therapy, Breathing Exercises, and Virtual Reality on Obstetric Recovery, Pain, and Gastrointestinal Symptoms After Cesarean Section
Cesarean Section, Cesarean Section Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-Linguistic Programming Techniques in people with Cesarean Section Complications, run by Toros University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stoma compliance scores of the participants (time frame: 1th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05646537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.