Effect of Acupressure Application on Patients' Nausea, Vomiting, Pain, and Sleep Quality

NCT05003284 | Completed

• 1 other identifier: tulay25
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to determine the effect of acupressure on nausea, vomiting, pain, and sleep quality after laparoscopic cholecystectomy. This was a randomized controlled experimental study with a placebo group. The sample comprised 188 patients who underwent laparoscopic cholecystectomy (control:64; experimental:64; and placebo:60). Acupressure was performed on the experimental and placebo groups with a wristband for 24 hours.

Conditions

Postoperative Complications

Keywords

acupressure; nausea-vomiting; nurse; pain; PC6; sleep

Outcome Measures

Primary Outcomes (4)

• Numeric nausea scale.

  The numeric nausea scale is a self-reported scale from 0 to 10, with 0 indicating "no nausea" and 10 indicating "very severe nausea" The highest nausea severity felt by the patient is marked on the scale

  up to 24 hours

• Visual analog scale

  The visual analog scale was used to evaluate the pain severity of the patient. It is a self-reported scale in the form of a 10-cm ruler indicating no pain at one end and unbearable pain at the other. Accordingly, the patient is told to evaluate his/her pain between 0 and 10, with 0 indicating "no pain" and 10 indicating "unbearable pain

  up to 24 hours

• Verbal category scale.

  The verbal category scale is a one-dimensional, simple, descriptive scale. Patients are asked to state the most appropriate word to describe their pain while filling in the scale. To describe the severity of pain, the patients had to choose from among (1) mild, (2) disturbing, (3) severe, (4) very severe, and (5) unbearable

  up to 24 hours

• Richards-Campbell Sleep Questionnaire

  Richards-campbell sleep questionnaire evaluates the depth of night sleep, sleep latency, number of awakenings, return to sleep, sleep quality, and the level of noise in the environment. It consists of six questions in total. Each item of the scale is evaluated with a visual analog scale ranging from 0 to 100. In this scale, "0-25" points indicate "very poor sleep" and "76-100" points indicate "very good sleep."

  To collect data on sleep, richards-campbell sleep questionnaire was applied to all three groups 24 hours after surgery to evaluate sleep, and the responses were recorded

Study Arms (2)

acupressure wristband

EXPERIMENTAL

On the day before the surgery, the patients in the experimental groups were introduced to the wristband and given an explanation regarding how it should be used. Approximately 30 minutes before the experimental group patients went to surgery, the PC6 acupressure point was determined for the patients. Immediately after the experimental group patients were taken to the wards after surgery, wristbands were placed on both wrists. İt was stated to the patients that the wristbands should remain on for 24 hours. The wristband was removed at the end of the 24th hour.

Device: acupressure wristband

placebo wristband

PLACEBO COMPARATOR

On the day before the surgery, the patients in the placebo groups were introduced to the wristband and given an explanation regarding how it should be used. Approximately 30 minutes before the placebo group patients went to surgery, the PC6 acupressure point was determined for the patients. Right after their surgery, patients in the placebo group were fitted with a wristband that looked the same as the acupressure wristband but did not have an acupressure application head. İt was stated to the patients that the wristbands should remain on for 24 hours. The wristband was removed at the end of the 24th hour.

Device: placebo wristband

Interventions

acupressure wristband DEVICE

acupressure after surgery

acupressure wristband

placebo wristband DEVICE

acupressure after surgery

placebo wristband

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18 and 65 years,
• Underwent laparoscopic cholecystectomy under general anesthesia,
• Conscious, were able to communicate, had no hearing or speech problems,
• Volunteered to participate were included in the study.

You may not qualify if:

• Patients who left the study at any stage,
• Taken to the intensive care unit in the early postoperative period, or underwent extra surgical interventions (e.g., hernia repair, etc.) were excluded from the study.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Tülay Kılınç

Erzurum, Palandöken, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Tülay kılınç, Dr

  Ataturk Unıversty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: August 12, 2021
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 25, 2020
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)