NCT06275165

Brief Summary

This study is a quasi-experimental design clinical trial with the primary objective of comparing the health status of patients with esophageal cancer. Participants were divided into an experimental group and a control group. Patients in the experimental group received routine care and acupressure for 5 consecutive days starting from the day after entering the ward after esophageal cancer surgery, in the control group, participants received routine care, and Participants were assessed on the Gastrointestinal Symptom Distress Scale at the end of the intervention. The aim of this study was to verify the effectiveness of acupressure in improving of gastrointestinal symptoms distress after esophageal cancer surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

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

First Submitted

Initial submission to the registry

February 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 27, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2025

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

February 17, 2024

Last Update Submit

August 6, 2025

Conditions

Keywords

gastrointestinal symptom distressacupressure

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in gastrointestinal symptom distress Scale at study day 5(end day)

    The Gastrointestinal Symptom Distress Scale is a validated self-report tool that assesses 10 gastrointestinal symptoms that patients with esophageal cancer may face after surgery. The 10-question questionnaire measures the self-perceived severity of nausea, vomiting, satiety, bloating, abdominal cramps, acid reflux, chest tightness, heart burn, diarrhea, and constipation, as well as the degree of interference with life. Using an 11-point Likert scale, 0 points (never happened), 1 point (very slight/very slight interference), 10 points (very severe/extreme interference), and the total score of the scale is 0-100 points. The higher the measured score, the more severe the gastrointestinal discomfort symptoms are and the more they interfere with life. The Gastrointestinal Symptom Distress Scale was subjected to an expert validity review, using the CVI (content validity index) calculation method, and the score was above 0.80.

    Baseline and study day 5

Study Arms (2)

acupressure

EXPERIMENTAL

Participants received routine care and acupressure.

Other: acupressure

no intervision

NO INTERVENTION

received routine care

Interventions

In the experimental group, routine nursing care and acupressure (Neiguan and Zusanli points) were performed from the 1st to the 5th day after the postoperative transfer from the ward to the hospital room. Twice a day, 3 minutes each time, 12 minutes in total.

acupressure

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized men and women who agree to participate in this study
  • Patients diagnosed with esophageal cancer based on pathological tissue section results
  • Nutritional support through jejunostomy in post esophagectomy patients
  • A sufficient level of education to understand study procedures and be able to communicate with site personnel

You may not qualify if:

  • Pregnant or lactating women
  • Diagnosed and treated for peripheral vascular disease within 3 months prior to surgery.
  • Those with unstable vital signs and septicemia infection after surgery.
  • Those who are suffering from blood diseases with abnormal coagulation function, or Currently taking anticoagulant drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memotial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Chia-Chen Chen

    Chang Gung Memorail Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were divided into an experimental group and a control group. experimental group: received acupressure for 5 days in addition to regular care. control group: received regular postoperative care.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2024

First Posted

February 23, 2024

Study Start

March 27, 2024

Primary Completion

July 18, 2025

Study Completion

July 18, 2025

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations