NCT06468345

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

May 22, 2024

Last Update Submit

June 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of pain after obesity surgery in the intervention, placebo and control groups with the Visual Analog pain scale

    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 Outcomes (1)

  • Evaluating the distension of patients after obesity surgery with the Abdominal Distension Form

    Distention of the patients was measured at the 24th postoperative hour.

Other Outcomes (3)

  • Measuring the gastrointestinal functions of patients after obesity surgery with the Gastrointestinal Functions Information Form

    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.

    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.

    The patients' anxiety was measured at the 24th hour after surgery.

Study Arms (3)

Acupressure Group

EXPERIMENTAL

Acupressure application to CV12, ST25, SP6, LI4 and HT7 areas

Behavioral: acupressure

Control Group

NO INTERVENTION

No action was taken.

Placebo Group

SHAM COMPARATOR

Massage application to feet, hands and abdomen areas that are not acupressure areas

Behavioral: Area different from acupressure area

Interventions

acupressureBEHAVIORAL

Application was made to CV12, ST25, SP6, HT7 and LI4 acupressure areas.

Acupressure Group

Massage application to non-acupressure hand, foot and abdominal areas

Placebo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Üniversitesi

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief investigator

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 21, 2024

Study Start

January 1, 2022

Primary Completion

February 20, 2023

Study Completion

March 15, 2023

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations