- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05033405
Neuro Linguistic Programming Pain Levels After Cesarean Delivery
August 27, 2021 updated by: Nursel Alp Dal, Munzur University
The Effect of Neuro Linguistic Programming on Pain Levels After Cesarean Delivery: A Randomized Controlled Trial
This study was conducted to determine the effect of Neuro-Linguistic Programming (NLP) application on post-cesarean section pain levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was carried out between March 1 and June 1, 2021 with mothers who gave birth through cesarean section in the postpartum service of a maternity and children's hospital in the most populated city of Turkey, which is located in the west.
The study data consists of a total of 76 individuals, including 38 in the experimental group and 38 in the control group.
In the study, the effect size was calculated as 2.22.
Accordingly, the power of the study, which was completed with 38 individuals in the control group and 38 in experimental group, had an effect size of 2.22, and used a significance level of 0.05, was calculated as 99.9%.
The power analysis was conducted on the G*Power software package.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tunceli, Turkey, 63000
- Nursel Alp Dal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
The study included individuals who
- had a cesarean section,
- were at the 6th to 24th hour postpartum,
- agreed to participate in the study,
- had a cesarean section for the first time,
- did not use patient-controlled analgesia (PCA),
- did not have an additional health problem that may cause pain in the postpartum period, other than cesarean incision pain, and
- could speak and understand Turkish.
Exclusion Criteria:
- Mothers who wanted to quit on their own will at any stage after being included in the study, had verbal communication problems, had hearing or vision problems, or had previously been diagnosed with a psychiatric illness were excluded from the sample.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental:Neuro Linguistic Programming
One session (20-minute long) of NLP application was performed.
The NLP techniques that were employed were representational systems and submodality.
In this technique, the sensory, auditory, and kinesthetic feelings of the individual are learned.
These emotions are modified by imagining.
The NLP application was carried out by a researcher who has a certificate in this field.
|
● One session (20-minute long) of NLP application was performed.
The NLP techniques that were employed were representational systems and submodality.
In this technique, the sensory, auditory, and kinesthetic feelings of the individual are learned.
These emotions are modified by imagining.
The NLP application was carried out by a researcher who has a certificate in this field
|
No Intervention: control group
No NLP was applied on the control group patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Examination of inter-and intra-group differences regarding VAS Scores
Time Frame: Immediately after the completion of the NLP application
|
A mean total score on the Visual Analogue Scale (VAS). In this assessment, users score their pain from 0 to 10. The scores are interpreted as follows: "0", no pain at all; 1-4, mild pain; 5-6, moderate pain; and 7-10, severe pain. A mean total score on the VAS of four and above indicates postoperative pain. |
Immediately after the completion of the NLP application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distribution of participant characteristics by groups
Time Frame: 20 minutes after the first administration of the VAS
|
The effect of NLP application on post-operative pain in women who gave birth by cesarean section is examined.
Comparisons are made by using Visual Analog Scale (VAS) mean scores in the experimental and control groups.
|
20 minutes after the first administration of the VAS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
June 1, 2021
Study Completion (Actual)
June 21, 2021
Study Registration Dates
First Submitted
August 18, 2021
First Submitted That Met QC Criteria
August 27, 2021
First Posted (Actual)
September 2, 2021
Study Record Updates
Last Update Posted (Actual)
September 2, 2021
Last Update Submitted That Met QC Criteria
August 27, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 047213793060212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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