Clinical trial NCT04288388: The Effect Of Ice Massage On Perceıved Pain
Official title: The Effect Of Ice Massage Applied To The Hand During Episiotomy Repair On Perceived Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Episiotomy Wound
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 347
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

18-40 years having a vaginal birth with episiotomy

Exclusion Criteria:

Under 18 years (adolesant women)

Primary outcomes:
measure: Vas
timeFrame: ten minute after ice massage
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Ege University
name: Birsen Karaca Saydam, PhD
role: STUDY_DIRECTOR
References: