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Dry Heat Versus Sitz Bath On Episiotomy Wound Heating And Pelvic Pain (Dry_Heat)

Primary Purpose

Wound Heal, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dry Heat Application
Moist Heat Application
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Wound Heal focused on measuring Infrared Rays, Heat, Hydrotherapy, episiotomy, Pelvic Pain, wound healing

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry heat group

Moist heat group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
December 23, 2021
Last Updated
December 23, 2021
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05186532
Brief Title
Dry Heat Versus Sitz Bath On Episiotomy Wound Heating And Pelvic Pain
Acronym
Dry_Heat
Official Title
To What Extent Does Application of Dry Heat is Effective in Promoting Episiotomy Wound Healing and Reducing Pelvic Pain Among Primipara Women?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.
Detailed Description
A quasi-experimental study was carried out at Abu EL-Matamer Central Hospital and Housh Issa Central Hospital. A sample of 100 postnatal women were randomly assigned into two equal groups. Women in the control group received the moist heat, which entails; sitting in a warm water tub up to the hip level. While, the study group were subjected to infra red-light therapy that supplies radiant heat or infra-red rays to produce heat to the episiotomy wound. Women who fulfilled the criteria from the postnatal inpatient ward at Abu EL-Matamer Central Hospital and Housh Issa Central Hospital in El-Beheira Governorate. Each woman was randomly assigned to one of the (dry heat or moist heat) groups. The researchers explained the aim of the study to every woman, and then her consent to participate in the study was obtained. All study subjects were individually interviewed by the researchers on the first two hours after delivery during hospital stay to collect the basic data, episiotomy pain intensity was assessed by, as well as the researchers inspect the episiotomy site for Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges using REEDA scale within 2 hours after episiotomy repair to evaluate wound healing (Pretest). After the assessment the researchers provided clear and concise information through illustrative pamphlet for the both groups. Dry heat group included 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. Moist 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. At the end of the session the researchers gave each woman health education about the importance of follow-up to ensure woman compliance for the interventions they assigned to it and to assess wound healing. The researchers motivated the women to perform the interventions they assigned to it through daily telephone calls by reminding the women with its benefits and importance of follow up. Follow up: Women of the two groups were instructed to come to the obstetric outpatient clinic at Abu EL-Matamer Central Hospital and Housh Issa Central Hospital for follow up visits during the morning shift on the 5th and 10th day post-partum, the perineal area was observed for redness, edema, ecchymosis, discharge and approximation of the skin as well as perineal pain. During each follow up visit the researchers had evaluated the episiotomy pain intensity using and episiotomy wound healing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Pain, Postoperative
Keywords
Infrared Rays, Heat, Hydrotherapy, episiotomy, Pelvic Pain, wound healing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry heat group
Arm Type
Experimental
Arm Description
infra red-light therapy that supplies radiant heat or infra-red rays to produce heat to the episiotomy wound.
Arm Title
Moist heat group
Arm Type
Active Comparator
Arm Description
warm sitz bath in which a woman is asked to sit in a warm water tub up to the hip level.
Intervention Type
Radiation
Intervention Name(s)
Dry Heat Application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moist Heat Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pelvic pain
Description
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
Time Frame
After 10 days
Title
Episiotomy wound healing
Description
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
Time Frame
After 10 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with normal vaginal delivery and episiotomy and
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Primipara First 2 hours after delivery Have a normal vaginal delivery Have episiotomy complaining of perineal discomfort (pain) Having a telephone for contact Exclusion Criteria: The women who were use any pain-relieving drug labor complications postpartum complications diabetes anemia Illiterate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman m Taha, professor
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Nursing
City
Alexandria
ZIP/Postal Code
56321
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24559056
Citation
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.
Results Reference
background
PubMed Identifier
27027195
Citation
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.
Results Reference
background
PubMed Identifier
22575710
Citation
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.
Results Reference
background
PubMed Identifier
21709521
Citation
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.
Results Reference
background
PubMed Identifier
31988645
Citation
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.
Results Reference
background

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Dry Heat Versus Sitz Bath On Episiotomy Wound Heating And Pelvic Pain

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