NCT05955352

Brief Summary

The goal of the clinical trial is to determine the effect of second-stage warm compress application on perineal pain and trauma among primiparous women. The main questions may reveal the pain intensity and the perineal outcome of the warm compress which might be helpful to the women during labor and related authority of the hospital. The intervention with warm perineal compression will be done among primiparous mothes during second stage of labor

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

June 21, 2023

Last Update Submit

December 14, 2023

Conditions

Keywords

perineal warm compression, Tear, Pain

Outcome Measures

Primary Outcomes (2)

  • level of pain intensity

    Pain intensity will be assessed using an NPRS after the application of warm compression on perineum during the second stage of labor and The scale ranges from 0 to 10, where 0 indicates no pain, and 10 represents the worst level of pain. In between these two extremes, words such as mild, moderate, severe, and very severe pain are assigned to each 2 cm distance on the line, respectively.

    15 minutes after application of warm compression

  • Perineal outcomes

    Perineal outcomes will be assessed as the degree of tears during childbirth as an effect of perineal warm compression

    1 hour after application of warm compression

Study Arms (1)

Procedural intervention and Control group with standard care

EXPERIMENTAL

There will be two groups. Interventional group will receive perineal warm compression and control group will receive standard care

Procedure: Perineal warm compression Technique

Interventions

There will be two groups. Interventional group will receive perineal warm compression and control group will receive standard care to asses the pain intensity and perineal tear

Also known as: Perineal heat therapy
Procedural intervention and Control group with standard care

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly Female
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tribhuvan University Teaching Hospital

Kathmandu, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

HyperthermiaPainLacerations

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and InjuriesNeurologic Manifestations

Study Officials

  • Isabel Lawot, MN

    Maharajgunj Nursing Campus, Tribhuvan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: there are two groups randomly selected. intervention and control group, One group will be used perineal heat application and the control group will be received standardized care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 21, 2023

First Posted

July 21, 2023

Study Start

February 20, 2023

Primary Completion

May 30, 2023

Study Completion

September 30, 2023

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations