NCT05033405

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

August 18, 2021

Last Update Submit

August 27, 2021

Conditions

Keywords

NLP, cesarean section, postpartum, pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately after the completion of the NLP application

Secondary Outcomes (1)

  • Distribution of participant characteristics by groups

    20 minutes after the first administration of the VAS

Study Arms (2)

Experimental:Neuro Linguistic Programming

EXPERIMENTAL

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.

Behavioral: NEURO-LINGUISTIC PROGRAMMING (NLP)

control group

NO INTERVENTION

No NLP was applied on the control group patients.

Interventions

● 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

Experimental:Neuro Linguistic Programming

Eligibility Criteria

Age19 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe mothers who gave birth through cesarean section in the postpartum service of a maternity and children's hospital
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursel Alp Dal

Tunceli, 63000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Neurolinguistic Programming

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Models, NeurologicalModels, BiologicalModels, TheoreticalInvestigative TechniquesModels, PsychologicalPsycholinguisticsBehavioral SciencesBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: The study was conducted by using a prospective randomized single-blind clinical trial model.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asis. Prof.

Study Record Dates

First Submitted

August 18, 2021

First Posted

September 2, 2021

Study Start

March 1, 2021

Primary Completion

June 1, 2021

Study Completion

June 21, 2021

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations