The Effects of Acupressure on Pain After Cesarean Section

NCT04337801 | Completed

• 1 other identifier: 03
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Women

Keywords

Acupressure; analgesia consumption; cesarean section; nursing; pain

Outcome Measures

Primary Outcomes (4)

• Pretest pain score in 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.

  Time 1 represents the measurement time before the intervention at postpartum second hour.

• Posttest pain score in 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.

  Time 2 represents the measurement time at 15 minutes after the intervention at postpartum second hour.

• Pretest pain score in 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.

  Time 3 represents the measurement time before the intervention at postpartum four hour.

• Posttest pain score in 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.

  Time 4 represents the measurement time at 15 minutes after the intervention at postpartum fourth hour.

Secondary Outcomes (2)

• 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.

Study Arms (3)

Acupressure

EXPERIMENTAL

The acupressure was carried out as two sessions, postpartum second (the first session of intervention) and fourth hours (the second session of intervention). The intervention was applied bilaterally and clockwise (left Pericardium 6, left Large Intestine 4, right Large Intestine 4 and right Pericardium 6) in this study. The acupressure was applied for three minutes in average, one minute for massage and two minutes for pressure per point; with an average of 12 minutes for the whole application. In addition, the pain score of the women was assessed by themselves through the VAS before the intervention (Time 1) and 15 minutes (Time 2) after the intervention at postpartum second hour. Also, it was assessed before the intervention (Time 3) and 15 minutes (Time 4) after the intervention at postpartum forth hour. Additionally, the analgesic substance and its amount applied during the application were recorded by the first researcher.

Other: Acupressure

Placebo

PLACEBO COMPARATOR

The Pericardium 6 and Large Intestine 4 points were slightly touched without pressure to women in the placebo group. Touches were applied to each acupressure point for three minutes similar to the acupressure group, each session of placebo lasted approximately 15 minutes. Similar to the acupressure group, In parallel with the acupressure, the pain score of the women was recorded at the postpartum second hour (Time 1) before intervention and 15 minutes later after intervention (Time 2), and at the fourth hour (Time 3) before intervention and 15 minutes later after intervention (Time 4). Additionally, the analgesic substance and its amount applied during the application were recorded by the researcher.

Other: Placebo

Control Group

NO INTERVENTION

No intervention was applied to the control group except for the routine nursing care. The data collection process in the control group was conducted in parallel with the acupressure and placebo groups. Pain score of women was recorded prior to intervention in the acupressure and placebo groups. The duration of intervention in the acupressure and placebo groups was 12 minutes and the measurements were repeated 15 minutes after the intervention. The average duration between the first and the second measurements is 30 minutes in the acupressure and placebo groups. In parallel with the acupressure and placebo groups, the current pain score of the women was recorded at the postpartum second hour (Time 1) and 30 minutes later (Time 2), and at the fourth hour (Time 3) and 30 minutes later (Time 4). Additionally, the analgesic substance and its amount applied during the application were recorded by the first researcher.

Interventions

Acupressure OTHER

The acupressure for symptom management is performed by pressing and scrubbing-like manipulations at certain points on the acupuncture meridians.

Also known as: Placebo

Acupressure

Placebo OTHER

The placebo intervention involves touching to the Pericardium 6 and Large Intestine 4 points without pressing.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32877509 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mehtap Akgün

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: April 8, 2020
• Study Start: July 15, 2017
• Primary Completion: July 15, 2018
• Study Completion: July 27, 2019
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)