Clinical trial NCT05311449: The Effect of Post-Cesarean Section Acupressure on the Severity of Pain and First Mobilization Distance
Official title: The Effect of Acupressure After Cesarean Section on Pain Intensity and First Mobilization Distance: A Double-Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Mobilization
Keywords: Post-cesarean
Acupressure
Pain
Step
Mobilization
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, two-arm, randomized controlled clinical trial, double blind
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled trial evaluates the effect of acupressure application on cesareans' pain and the number of steps in the first mobilization. This study hypothesizes that acupressure reduces pain and improves number of steps.

Detailed description: Methods: In the study, 64 cesareans will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 32), an average of 15 minutes will be applied to the LI4 (liver), P6 (pericardium) and the Sanyinjia points on the splenic meridian (SP6) located on the inner side of the lower leg, four fingers above the ankle and behind the tibia. In the placebo acupressure group (n = 32), the points 1.5 cm away from the LI4, P6 and SP6 points (four points in total) will be applied for an average of 15 minutes. The primary outcome of the research is the effect of acupressure on the pain of cesareans. The secondary outcome of the study is to determine the effect of acupressure on the number of steps. The pain will be collected before and 1 minute, 2nd and 4th hour after acupressure and placebo acupressure administration. The number of steps will be collected 4th hour after acupressure and placebo acupressure administration.

Eligibility criteria: Inclusion Criteria:

* Being conscious,
* The mother tongue is Turkish,
* To be oriented and cooperative,
* be between 18-45 years old,
* To voluntarily agree to participate in the study (signing the Informed Consent Form),
* Repeated cesarean section,
* Cesarean section under spinal anesthesia,
* Not having a risky pregnancy (preeclampsia, gestational diabetes etc.),
* No health problems of the fetus,
* To have given birth by cesarean section between 37-40 weeks,
* To be in the second hour of the postpartum period,
* Not receiving post-op patient-controlled analgesia,
* Not to have smoked or used alcohol during pregnancy,
* No complications in the mother and/or newborn after cesarean section,
* No sensitivity in the area where acupressure will be applied,
* Absence of any systemic or psychiatric diagnosis,
* Absence of active COVID-19 infection.

Exclusion Criteria:

* Lack of consciousness,
* The mother tongue is not Turkish,
* Not oriented and cooperative,
* Not to be between the ages of 18-45,
* Refusal to voluntarily participate in the study (those who did not sign the Informed Consent Form),
* Normal birth or cesarean delivery under general anesthesia,
* Cesarean delivery due to the risk of deterioration of maternal or fetal health,
* Not having had a risky pregnancy (preeclampsia, gestational diabetes, etc.),
* Not giving birth outside 37-40 weeks and by cesarean section,
* Not in the second hour of the postpartum period,
* Receiving post-op patient-controlled analgesia,
* To have used cigarettes and alcohol during pregnancy,
* Sensitivity in the area where acupressure will be applied,
* Presence of any systemic or psychiatric diagnosis,
* Active COVID-19 infection.

Primary outcomes:
measure: Pain evaluated using the visual analog scale
timeFrame: Change from before implementation and after 1 minute, 2nd and 4th hour after implementation
Secondary outcomes:
measure: The number of steps using step counter (TNV 3D Pedometer (Model: PM2000, Made in China)
timeFrame: Change 4th hour after acupressure
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
state: Yenişehir
Study officials:
affiliation: Mersin University
name: Duygu VEFİKULUÇAY YILMAZ, Doctorate
role: STUDY_DIRECTOR
affiliation: Mersin University
name: Aslıhan AKSU, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Filiz DEĞİRMENCİ, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Gülay ALTUN UĞRAŞ, doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin City Hospital
name: Mürşide ÇEVİKOĞLU KILLI, doctorate
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen Y, Xiang XY, Chin KHR, Gao J, Wu J, Lao L, Chen H. Acupressure for labor pain management: a systematic review and meta-analysis of randomized controlled trials. Acupunct Med. 2021 Aug;39(4):243-252. doi: 10.1177/0964528420946044. Epub 2020 Aug 18.
citation: Smith CA, Collins CT, Levett KM, Armour M, Dahlen HG, Tan AL, Mesgarpour B. Acupuncture or acupressure for pain management during labour. Cochrane Database Syst Rev. 2020 Feb 7;2(2):CD009232. doi: 10.1002/14651858.CD009232.pub2.
citation: Akgun M, Boz I. The effects of acupressure on post-cesarean pain and analgesic consumption: a randomized single-blinded placebo-controlled study. Int J Qual Health Care. 2020 Nov 16;32(9):609-617. doi: 10.1093/intqhc/mzaa107.