Acupressure Application in Obesity Surgery 2345 (DB)

June 15, 2024 updated by: Duygu Balaban, Ataturk University

The Effect of Acupressure Applied After Bariatric Surgery on Gastrointestinal Functions, Pain and Anxiety

This research was conducted to determine the effect of acupressure applied to patients after bariatric surgery on gastrointestinal distress, pain and anxiety. The data of the study was collected at Aktif Private Kocaeli Hospital General Surgery Clinic between January 2022 and February 2023. The study was conducted with 90 (30 control, 30 intervention and 30 placebo) patients who underwent bariatric surgery. As a result of the research, application to ST25 and CV12 acupressure areas after bariatric surgery increased gas and stool output. It reduced abdominal distension. This enabled patients to start oral intake early. Application to the SP6 area reduced abdominal pain. Acupressure applied to the LI4 area was not effective in reducing nausea and vomiting. Massage to the HT7 acupressure area alone was not sufficient to relieve anxiety.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This research was conducted to determine the intensity of acupressure treatment for gastrointestinal problems, pain and anxiety after bariatric surgery. The research was conducted using a placebo group, randomized controlled, detailed research model. The data of the study was collected at Aktif Private Kocaeli Hospital General Surgery Clinic between January 2022 and February 2023. The study was conducted with 90 (30 control, 30 intervention and 30 placebo) patients who underwent bariatric surgery. The data were brought together with the patient identification formula, postoperative gastrointestinal functions information formula, abdominal distension formula, visual analog scale, state-trait anxiety inventory scale, visual comparison operation, and patient happiness formula. The data were analyzed with the SPSS for Windows 22 package program. Records of numbers, percentages, minimum and maximum values, averages and standard deviations in the analysis of data. Mann Whitney U analysis, LSD, Dunnet C, Kruskall Wallis, Will coxon analyzes and t test records. The results were interpreted at the p< 0.05 significance level. Gastrointestinal capacity and recovery time, stool and gas output rates, difference in distension and abdominal pain score amounts, oral intake amounts and retching difference of the patients in acupressure, control and placebo distribution at the 6th, 12th, 24th and 48th months of the surgery were investigated. Children's movements and vomiting were evaluated with visual comparison performance. Anxiety was measured with the State-Trait Anxiety Inventory Scale at the ages of 6, 12, 24 and 48 after treatment. He recorded the Patient Satisfaction Form to obtain the patients' satisfaction after acupressure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey
        • Atatürk Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients undergoing Bariatric Surgery
  • Conscious patients between the ages of 18-65
  • Patients who can communicate
  • Patients without hearing-speech problems
  • Patients without any psychiatric disorder
  • Patients willing to cooperate
  • Patients who have never had acupressure before
  • Patients who do not have conditions such as hematoma, wound or fracture in the areas where acupressure will be applied

Exclusion Criteria:

  • Patients who withdraw from the study at any stage of the study
  • Patients admitted to the intensive care unit in the early postoperative period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acupressure Group
Acupressure application to CV12, ST25, SP6, LI4 and HT7 areas
Behavioral: acupressure
Application was made to CV12, ST25, SP6, HT7 and LI4 acupressure areas.
No Intervention: Control Group
No action was taken.
Sham Comparator: Placebo Group
Massage application to feet, hands and abdomen areas that are not acupressure areas
Behavioral: Area different from acupressure area
Massage application to non-acupressure hand, foot and abdominal areas

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of pain after obesity surgery in the intervention, placebo and control groups with the Visual Analog pain scale
Time Frame: Pain was assessed at 24 hours postoperatively.
On the Visual Analog pain scale, a score of 0 means no pain and 10 means unbearable pain.
Pain was assessed at 24 hours postoperatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluating the distension of patients after obesity surgery with the Abdominal Distension Form
Time Frame: Distention of the patients was measured at the 24th postoperative hour.
The Abdominal Distension Form ranges from 0 to no distension and 10 to severe distension.
Distention of the patients was measured at the 24th postoperative hour.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measuring the gastrointestinal functions of patients after obesity surgery with the Gastrointestinal Functions Information Form
Time Frame: Gastrointestinal functions of the patients were measured at 6, 12, 24 and 48 hours after surgery.
The Gastrointestinal Functions Information Form includes a total of 6 questions about the patients' stool output, gas output, oral intake amount, nausea, vomiting and retching. Patients have two ways of answering: yes or no.
Gastrointestinal functions of the patients were measured at 6, 12, 24 and 48 hours after surgery.
Measuring nausea and vomiting in patients after obesity surgery with the Visual Comparison Scale.
Time Frame: Measurements were taken at 6, 12, 24 and 48 hours after surgery.
In the Visual Comparison Scale, the lowest value of the patients' nausea and vomiting was used as 0 mm, and the highest value was 100 mm.
Measurements were taken at 6, 12, 24 and 48 hours after surgery.
Measuring the anxiety of patients after bariatric surgery with the State-Trait Anxiety Inventory.
Time Frame: The patients' anxiety was measured at the 24th hour after surgery.
There are two forms in the State-Trait Anxiety Inventory questionnaire. The first form consists of 20 questions measuring the state anxiety of the patients, and the second form contains 20 questions measuring the trait anxiety of the patients. The lowest score in these questions is 1 and the highest score is 4.
The patients' anxiety was measured at the 24th hour after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DBalaban

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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