NCT06194890

Brief Summary

Having a patient with pain watch a video can be used to "direct attention to a different direction", which is a part of nursing care in pain management (İnal and Canbulat, 2015). There are studies using different non-invasive methods to reduce pain during labor (Ebrahimian and Bilandi, 2021; Kazeminia et al., 2020). However, no randomized controlled study has been found in which comedy videos were watched for labor pain management and birth satisfaction. For this reason, it is planned to investigate the effect of comedy video on pain and birth satisfaction in this study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2024

Completed
Last Updated

January 8, 2024

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

December 22, 2023

Last Update Submit

December 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    Visual Analog Scale for labor pain

    in the labor's 4-6, 6-8,8-10 cm cervical opening

Secondary Outcomes (1)

  • Birth satisfaction scale

    In the 4th stage of labor

Study Arms (2)

Control group

NO INTERVENTION

When the patients are admitted, their written consent will be obtained and personal information forms and the Visual Comparison Scale (VAS) pain scale will be applied to all participants. VAS pain scale will be applied to both groups during the active phase of labor with 6-8 cm dilatation and 8-10 cm dilatation phases. At the end of the labor, the "Birth Satisfaction Scale Short Form" will be applied to both groups.

Intervention group

EXPERIMENTAL

When the patients are admitted, their written consent will be obtained and personal information forms and the Visual Comparison Scale (VAS) pain scale will be applied to all participants. Women in the experimental group will watch a 15-20 minute video with comedy content during the active phase of the action (4-6 cm dilation), and no intervention will be made to women in the control group. VAS pain scale will be applied to both groups during the active phase of labor with 6-8 cm dilatation and 8-10 cm dilatation phases. At the end of the labor, the "Birth Satisfaction Scale Short Form" will be applied to both groups.

Other: Distraction technique with comedy video

Interventions

Women in the intervention group will watch an average of 6 minutes of comedy videos during the active phase, transition phase and latent phase of labor.

Intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIn the labor
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being in the active phase of labor,
  • Being between the ages of 18-45,
  • Knowing Turkish,
  • Not having a high-risk pregnancy diagnosis,
  • Being over 37 weeks gestational age,
  • Volunteering to participate in research.

You may not qualify if:

  • Not knowing Turkish,
  • Being diagnosed with a high-risk pregnancy,
  • The gestational age is less than 37 weeks,
  • Having passed the active phase of labor or being in the latent phase.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Yıldırım

Çorum, 19600, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 8, 2024

Study Start

December 8, 2023

Primary Completion

February 8, 2024

Study Completion

April 8, 2024

Last Updated

January 8, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations