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The Effect Of Ice Massage On Perceıved Pain

NCT ID: NCT04288388

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2018-12-15

Brief Summary

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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

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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.

Conditions

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Labor Pain Episiotomy Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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massage group

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).

Group Type EXPERIMENTAL

massage group

Intervention Type BEHAVIORAL

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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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massage group

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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ice massage

Eligibility Criteria

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Inclusion Criteria

18-40 years having a vaginal birth with episiotomy

Exclusion Criteria

Under 18 years (adolesant women)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Bihter Akın

Asisstant Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birsen Karaca Saydam, PhD

Role: STUDY_DIRECTOR

Ege University

Locations

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Selcuk University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Ice Massage

Identifier Type: -

Identifier Source: org_study_id