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The Effect Of Ice Massage On Perceıved Pain (icemassage)

Primary Purpose

Labor Pain, Episiotomy Wound

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
massage group
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

18-40 years having a vaginal birth with episiotomy

Exclusion Criteria:

Under 18 years (adolesant women)

Sites / Locations

  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

massage group

Control group

Arm Description

Immediately before the episiotomy repair was started (after exit of placenta and applying local anesthetic agent), women assigned to the study (massage) group were asked to place plastic gloves filled with ice pieces in the LI4 point on hand. This application was made for 5 minutes to the right hand and for 5 minutes to the left hand. The episiotomy was opened by the same midwife as all the women to the right mediolateral and repaired by the same midwife with the same technique and material.The ice massage was repeated until the episiotomy repair was over; total massage time and episiotomy repair time were recorded. Women were asked to mark the perceived pain level before the application and at the end of the application using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair).

I the control group women were not excluded from routine practice; women were asked to mark the perceived pain level before episiotomy repair begin and at the end the repair using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair) like the study (massage) group.

Outcomes

Primary Outcome Measures

Vas
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients (knee replacement, hyster-ectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

Secondary Outcome Measures

Full Information

First Posted
February 7, 2020
Last Updated
February 25, 2020
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT04288388
Brief Title
The Effect Of Ice Massage On Perceıved Pain
Acronym
icemassage
Official Title
The Effect Of Ice Massage Applied To The Hand During Episiotomy Repair On Perceived Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
December 15, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Introduction: In this study, it was aimed to examine the effect of ice massage applied to the hand during episiotomy repair on perceived pain. Methods: The study was carried out in the delivery unit of a maternity hospital between April 15, 2018 and November 15, 2018 with vaginal delivery for the first time, no complication developed during the delivery, with the study group being 178 and the control group being 169 with 347 women. Immediately before the episiotomy repair was started (after exit of placenta and applying local anesthetic agent), women assigned to the study (massage) group were asked to place plastic gloves filled with ice pieces in the LI4 point on hand. This application was made for 5 minutes to the right hand and for 5 minutes to the left hand. The episiotomy was opened by the same midwife as all the women to the right mediolateral and repaired by the same midwife with the same technique and material.The ice massage was repeated until the episiotomy repair was over; total massage time and episiotomy repair time were recorded. Women were asked to mark the perceived pain level before the application and at the end of the application using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair). In the control group women were not excluded from routine practice; women were asked to mark the perceived pain level before episiotomy repair begin and at the end the repair using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair) like the study (massage) group. Data were evaluated by using chi square, student t test and ANOVA in SPSS 18.0 program. In order to carry out this study , the necessary consent was obtained from the ethics committee, institution and women.
Detailed Description
Introduction: Episiotomy is the most common surgical intervention during vaginal delivery. Perineal damage during this incision causes perineal pain; pain and anxiety levels of women increase during episiotomy repair as well as during labor and delivery. In order to minimize this level of pain, local anesthetic agents are routinely administered to the episiotomy region. In recent years, in the literature, it is known that many non-pharmacological techniques are applied to reduce the pain of birth in addition to local anesthesia. One of these nonpharmacological methods is the application of pressure to LI4 point on hand with ice. Although there are studies conducted to reduce the pain with LI4 point in the literature, the studies done to reduce the pain experienced during episiotomy repair are quite limited.In this study, it was aimed to examine the effect of ice massage applied to the hand during episiotomy repair on perceived pain. Methods: The study was carried out in the delivery unit of a maternity hospital between April 15, 2018 and November 15, 2018 with vaginal delivery for the first time, no complication developed during the delivery, with the study group being 45 and the control group being 60 with 105 women. Immediately before the episiotomy repair was started (after exit of placenta and applying local anesthetic agent), women assigned to the study (massage) group were asked to place plastic gloves filled with ice pieces in the LI4 point on hand. This application was made for 5 minutes to the right hand and for 5 minutes to the left hand. The episiotomy was opened by the same midwife as all the women to the right mediolateral and repaired by the same midwife with the same technique and material.The ice massage was repeated until the episiotomy repair was over; total massage time and episiotomy repair time were recorded. Women were asked to mark the perceived pain level before the application and at the end of the application using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair). In the control group women were not excluded from routine practice; women were asked to mark the perceived pain level before episiotomy repair begin and at the end the repair using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair) like the study (massage) group. Data were evaluated by using chi square, student t test and ANOVA in SPSS 18.0 program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Episiotomy Wound

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study group being 178 and the control group being 169 with 347 women. Immediately before the episiotomy repair was started (after exit of placenta and applying local anesthetic agent), women assigned to the study (massage) group were asked to place plastic gloves filled with ice pieces in the LI4 point on hand. This application was made for 5 minutes to the right hand and for 5 minutes to the left hand. Women were asked to mark the perceived pain level before the application and at the end of the application using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair). In the control group women were not excluded from routine practice; women were asked to mark the perceived pain level before episiotomy repair begin and at the end the repair using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair) like the study (massage) group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
massage group
Arm Type
Experimental
Arm Description
Immediately before the episiotomy repair was started (after exit of placenta and applying local anesthetic agent), women assigned to the study (massage) group were asked to place plastic gloves filled with ice pieces in the LI4 point on hand. This application was made for 5 minutes to the right hand and for 5 minutes to the left hand. The episiotomy was opened by the same midwife as all the women to the right mediolateral and repaired by the same midwife with the same technique and material.The ice massage was repeated until the episiotomy repair was over; total massage time and episiotomy repair time were recorded. Women were asked to mark the perceived pain level before the application and at the end of the application using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
I the control group women were not excluded from routine practice; women were asked to mark the perceived pain level before episiotomy repair begin and at the end the repair using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair) like the study (massage) group.
Intervention Type
Behavioral
Intervention Name(s)
massage group
Other Intervention Name(s)
ice massage
Intervention Description
In recent years, in the literature, it is known that many non-pharmacological techniques are applied to reduce the pain of birth in addition to local anesthesia. One of these nonpharmacological methods is the application of pressure to LI4 point on hand with ice.
Primary Outcome Measure Information:
Title
Vas
Description
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients (knee replacement, hyster-ectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Time Frame
ten minute after ice massage

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-40 years having a vaginal birth with episiotomy Exclusion Criteria: Under 18 years (adolesant women)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birsen Karaca Saydam, PhD
Organizational Affiliation
Ege University
Official's Role
Study Director
Facility Information:
Facility Name
Selcuk University
City
Konya
ZIP/Postal Code
42100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect Of Ice Massage On Perceıved Pain

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