NCT05186532

Brief Summary

Objective: To compare the effect of dry heat versus moist heat application on episiotomy wound healing and pain among postnatal mothers. Research hypothesis H0: Postnatal mothers who apply dry heat on their episiotomy wound experience the same wound healing and pain as those who apply moist heat. H1: Postnatal mothers who apply dry heat on their episiotomy wound experience faster wound healing and less pain than those who apply moist heat. H2: Postnatal mothers who apply moist heat on their episiotomy wound experience faster wound healing and less pain than those who apply dry heat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

January 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

December 23, 2021

Last Update Submit

December 23, 2021

Conditions

Keywords

Infrared RaysHeatHydrotherapyepisiotomyPelvic Painwound healing

Outcome Measures

Primary Outcomes (2)

  • Pelvic pain

    The researchers measured the pelvic pain intensity using Visual analogue scale: This scale was adopted and translated to an Arabic version to be used in the current study. It was developed by Melzack and Katz (1994). It is a self-reported device consisting of a horizontal line used for subjective estimation of patient's pain. It comprises 10-point numerical scale, corresponding to the degree of pain with zero representing no pain and 10 representing the worst degree of pain. Scores 1, 2, 3 indicate mild pain, while 4, 5, 6 scores indicate moderate pain and 7, 8, 9 scores indicate severe pain; finally, 10 indicate the worst unbearable pain

    After 10 days

  • Episiotomy wound healing

    The researchers assessed episiotomy wound healing using The standardized Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale ; The REEDA scale is an observational check list used for assessing perineal wound healing that was primarily developed by Davidson (1974). It can be used to assess all types of postpartum perineal trauma. It has five components namely Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges. Each component takes a score ranged from 0 to 3 . Total REEDA score ranges between 0 and 15. Higher score indicates poor wound healing while lower score indicates good wound healing. The total score of REEDA scale was categorized as follows; Completely healed from 0 to 2 , Moderately healed from 3 to 5 , Mildly healed from 6 to 8, and Not healed from 9 to 15

    After 10 days

Study Arms (2)

Dry heat group

EXPERIMENTAL

infra red-light therapy that supplies radiant heat or infra-red rays to produce heat to the episiotomy wound.

Radiation: Dry Heat Application

Moist heat group

ACTIVE COMPARATOR

warm sitz bath in which a woman is asked to sit in a warm water tub up to the hip level.

Other: Moist Heat Application

Interventions

50 postnatal women they were encouraged to place an infrared lamp at distance of 45 cm from the perineum and the heat produced with 230 volts for ten minutes. But the mother is checked after the first five minutes to make sure that she was not being burned. The researchers were demonstrated for each woman how to use infrared lamp, and it was followed by re demonstrations and discussions. After 12 hours of episiotomy this procedure was carried out in the morning and evening for ten consecutive days. The researcher gives the infrared lamp device for each woman then restore it after completion of the study.

Dry heat group

included 50 postnatal women they were encouraged to sit in a basin (tub) of warm water (45 o C -59 o C) without pressure on the perineum and with the feet flat on the floor for 10 minutes. The researchers were demonstrated for each woman how to do warm sitz bath, and it was followed by re demonstrations and discussions. After 12 hours of episiotomy this procedure was carried out in the morning and evening for ten consecutive days.

Moist heat group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with normal vaginal delivery and episiotomy and
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primipara
  • First 2 hours after delivery
  • Have a normal vaginal delivery
  • Have episiotomy
  • complaining of perineal discomfort (pain)
  • Having a telephone for contact

You may not qualify if:

  • The women who were
  • use any pain-relieving drug
  • labor complications
  • postpartum complications
  • diabetes
  • anemia
  • Illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Alexandria, 56321, Egypt

Location

Related Publications (5)

  • Priddis H, Schmied V, Dahlen H. Women's experiences following severe perineal trauma: a qualitative study. BMC Womens Health. 2014 Feb 21;14(1):32. doi: 10.1186/1472-6874-14-32.

    PMID: 24559056BACKGROUND
  • Steen M, Cummins B. How to alleviate perineal pain following an episiotomy. Nurs Stand. 2016 Mar 30;30(31):34-7. doi: 10.7748/ns.30.31.34.s43. No abstract available.

    PMID: 27027195BACKGROUND
  • Swain J, Dahlen HG. Putting evidence into practice: a quality activity of proactive pain relief for postpartum perineal pain. Women Birth. 2013 Mar;26(1):65-70. doi: 10.1016/j.wombi.2012.03.004. Epub 2012 May 8.

    PMID: 22575710BACKGROUND
  • Petersen MR. Review of interventions to relieve postpartum pain from perineal trauma. MCN Am J Matern Child Nurs. 2011 Jul-Aug;36(4):241-5. doi: 10.1097/NMC.0b013e3182182579.

    PMID: 21709521BACKGROUND
  • Sarbaz Z, Yazdanpanahi Z, Hosseinkhani A, Nazari F, Akbarzadeh M. The Effect of Sitz Bath of Hydro-Alcoholic Extract of Myrrh Gum on Episiotomy Wound Healing in Nulliparous Women. J Family Reprod Health. 2019 Jun;13(2):89-97.

    PMID: 31988645BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePelvic Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Eman m Taha, professor

    Alexandria University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 11, 2022

Study Start

January 5, 2021

Primary Completion

June 30, 2021

Study Completion

July 1, 2021

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations