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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04288388
Other study ID # Ice Massage
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date December 15, 2018

Study information

Verified date February 2020
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 347
Est. completion date December 15, 2018
Est. primary completion date November 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

18-40 years having a vaginal birth with episiotomy

Exclusion Criteria:

Under 18 years (adolesant women)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Turkey Selcuk University Konya

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) ten minute after ice massage
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