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Neuro Linguistic Programming Pain Levels After Cesarean Delivery

Primary Purpose

Nursing Caries, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
NEURO-LINGUISTIC PROGRAMMING (NLP)
Sponsored by
Munzur University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nursing Caries focused on measuring NLP, cesarean section, postpartum, pain

Eligibility Criteria

19 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Nursel Alp Dal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental:Neuro Linguistic Programming

control group

Arm Description

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 NLP was applied on the control group patients.

Outcomes

Primary Outcome Measures

Examination of inter-and intra-group differences regarding VAS Scores
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.

Secondary Outcome Measures

Distribution of participant characteristics by groups
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.

Full Information

First Posted
August 18, 2021
Last Updated
August 27, 2021
Sponsor
Munzur University
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1. Study Identification

Unique Protocol Identification Number
NCT05033405
Brief Title
Neuro Linguistic Programming Pain Levels After Cesarean Delivery
Official Title
The Effect of Neuro Linguistic Programming on Pain Levels After Cesarean Delivery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Munzur University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was conducted to determine the effect of Neuro-Linguistic Programming (NLP) application on post-cesarean section pain levels.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursing Caries, Pain, Postoperative
Keywords
NLP, cesarean section, postpartum, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The study was conducted by using a prospective randomized single-blind clinical trial model.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental:Neuro Linguistic Programming
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No NLP was applied on the control group patients.
Intervention Type
Behavioral
Intervention Name(s)
NEURO-LINGUISTIC PROGRAMMING (NLP)
Intervention Description
● 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
Primary Outcome Measure Information:
Title
Examination of inter-and intra-group differences regarding VAS Scores
Description
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.
Time Frame
Immediately after the completion of the NLP application
Secondary Outcome Measure Information:
Title
Distribution of participant characteristics by groups
Description
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.
Time Frame
20 minutes after the first administration of the VAS

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The mothers who gave birth through cesarean section in the postpartum service of a maternity and children's hospital
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nursel Alp Dal
City
Tunceli
ZIP/Postal Code
63000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Neuro Linguistic Programming Pain Levels After Cesarean Delivery

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