The Effects of Acupressure on Pain After Cesarean Section: Randomized, Single-Blind, Placebo and Control Group Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Akdeniz University
- Enrollment
- 132
- Locations
- 2
- Primary Endpoint
- Pretest pain score in postpartum fourth hour
Study Overview
Brief Summary
Purpose: To examine the effect of Pericardium 6 and Large Intestine 4 acupressure on pain and analgesia consumption in women after cesarean section.
Methods: This study was conducted in a randomized, single-blind, placebo and control group study design with 132 women, including acupressure (n=44), placebo (n=44), and control (n=44) groups. Acupressure was administered to the Pericardium 6 and Large Intestine 4 points in the second and fourth hours after cesarean section. Data were collected using the personal information form and Visual Analog Scale. This study was used the CONSORT scheme.
Detailed Description
This study was conducted in a randomized, single-blind, placebo and control group study design. The setting was a metropolitan university hospital in Turkey. The hospital had Gynecology and Obstetrics Clinics with 56 beds with 32 nurses. The study was carried out between July 2017 and July 2018 with women who voluntarily participated in the study at the second after cesarean section
A sample size was calculated using G*Power version 3. In calculating the sample size of the study, the confidence interval was determined as 95%, the power of the study was 80% and the effect size was 0.8. Based on these reference values, the sample size was determined as 114 women. However, with a 10% loss rate, the total sample size was increased to 132, comprised of the acupressure group (n=44), the placebo group (n=44), and the control group (n=44). In the data collection process, 416 women were reached.
In this study, since the parity and the type of anesthesia were the variables to be controlled, block randomization method was preferred. The version 8.2 of the Statistical Analysis System was used to determine randomization by second researcher. By creating a randomization list through the program, the multipara and primipara women and women who experienced general and spinal anesthesia were equally divided into three groups as acupressure, placebo, and control groups.
In this study, it was ensured that the women participating in the study did not know which group they were in, and thus, a one-way blinding was performed. This was performed by using closed envelope method. The participants were masked so that the women in the acupressure and placebo groups were not informed about the pressure severity applied to the acupressure points. The nurse practitioner (MA) was couldn't unmasked because of conducting the intervention in this study. Also, the statistician wasn't masked.
In the hospital where the study was conducted, women are monitored in the recovery unit for approximately one and a half hour after cesarean section. Women are then transported to the clinic. In this study, the analgesia protocol of the Akdeniz University Hospital Obstetrics and Gynecology Department was administered by the nurses to all three groups, which are acupressure, placebo, and control group. According to the analgesia protocol, in pain management after cesarean section, primarily the diclofenac sodium is administered to the women and pain score is observed. Diclofenac sodium treatment applied in the recovery unit is reported to the nurses during the transportation of the woman to the clinic. If diclofenac sodium was not administered to the women in the recovery unit, diclofenac sodium is applied through the intra muscular (IM) to them just after hospitalization following the cesarean section. Subsequent to the use of diclofenac sodium, the women are evaluated for pain score and treatment is continued with either of the analgesia among pethidine hydrochloride, diclofenac sodium, and paracetamol. Maintaining analgesia at plasma concentration is important in pain management. Maintaining analgesia in plasma concentration in women after cesarean section is performed with paracetamol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Masking Description
In this study, it was ensured that the women participating in the study did not know which group they were in, and thus, a one-way blinding was performed. This was performed by using closed envelope method. The participants were masked so that the women in the acupressure and placebo groups were not informed about the pressure score applied to the acupressure points.
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •to be between 18-45 years old
- •to give a birth by cesarean section between 37-40 weeks
- •to give a birth to a healthy baby at the end of a singleton pregnancy
- •to be in the postpartum second hour
- •to have no problem that prevents verbal communication
Exclusion Criteria
- •to have the cesarean section after a high-risk pregnancy
- •to have severe systemic diseases
- •to have complications in the mother and/or the newborn after cesarean section
- •to be administered patient controlled analgesia
- •to have a body mass index over 25 kg/m2
- •to have a previous acupressure experience
- •to have intracath on the area of intervention
- •to have smoking and alcohol use during pregnancy.
Outcomes
Primary Outcomes
Pretest pain score in postpartum fourth hour
Time Frame: Time 3 represents the measurement time before the intervention at postpartum four hour.
The pain score of the women was assessed by themselves through the Visual Analog Scale (VAS). The VAS is a ruler scale with a length of 10 cm, which is prepared with 1 cm intervals. On the scale, 0 stands for "no pain", 10 means "unbearable pain". In this study, the VAS was used in vertical format. Women were asked to mark their pain score on the scale.
Pretest pain score in postpartum second hour
Time Frame: Time 1 represents the measurement time before the intervention at postpartum second hour.
The pain score of the women was assessed by themselves through the Visual Analog Scale (VAS). The VAS is a ruler scale with a length of 10 cm, which is prepared with 1 cm intervals. On the scale, 0 stands for "no pain", 10 means "unbearable pain". In this study, the VAS was used in vertical format. Women were asked to mark their pain score on the scale.
Posttest pain score in postpartum fourth hour
Time Frame: Time 4 represents the measurement time at 15 minutes after the intervention at postpartum fourth hour.
The pain score of the women was assessed by themselves through the Visual Analog Scale (VAS). The VAS is a ruler scale with a length of 10 cm, which is prepared with 1 cm intervals. On the scale, 0 stands for "no pain", 10 means "unbearable pain". In this study, the VAS was used in vertical format. Women were asked to mark their pain score on the scale.
Posttest pain score in postpartum second hour
Time Frame: Time 2 represents the measurement time at 15 minutes after the intervention at postpartum second hour.
The pain score of the women was assessed by themselves through the Visual Analog Scale (VAS). The VAS is a ruler scale with a length of 10 cm, which is prepared with 1 cm intervals. On the scale, 0 stands for "no pain", 10 means "unbearable pain". In this study, the VAS was used in vertical format. Women were asked to mark their pain score on the scale.
Secondary Outcomes
- Analgesic consumption before intervention at postpartum second hour(It includes the time from delivery to first intervention at the second hour of postpartum)
- Analgesic consumption during the process after the intervention at the second hour after birth(It includes an average of 3 hour from immediately after the interventions at second hour of postpartum to study completion.)
Investigators
Ilkay Arslan
Principal Investigator
Akdeniz University
