NCT07100015

Brief Summary

This randomized controlled trial compared the effects of shoulder massage and therapeutic touch on pain and anxiety after laparoscopic cholecystectomy. Both interventions significantly reduced pain and anxiety levels compared to the control group. Shoulder massage was more effective in reducing pain, while therapeutic touch was more effective in reducing anxiety. These methods are recommended for broader use in clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

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

April 17, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

14 days

First QC Date

June 14, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

Painanxiety,laparoscopic cholecystectomy,massage,theropathic touch

Outcome Measures

Primary Outcomes (2)

  • For shoulder pain: Measured with the Visual Analog Scale (VAS).

    Shoulder Pain Intensity Assessed by Visual Analog Scale (VAS)

    four month

  • For anxiety: The State-Trait Anxiety Inventory (STAI) was used.

    State-Trait Anxiety Inventory (STAI) Score for Anxiety Assessment

    four month

Study Arms (3)

Control Group

ACTIVE COMPARATOR

in which patients did not receive any treatment and received routine postoperative care in the clinic.

Device: Control Group

Therapeutic touch

EXPERIMENTAL

in which therapeutic touch was applied

Device: therapeutic touch

Shoulder massage group

EXPERIMENTAL

in which shoulder massage was applied

Device: Shoulder massage

Interventions

in which patients did not receive any treatment and received routine postoperative care in the clinic

Control Group

Therapeutic touch applications

Therapeutic touch

shoulder massage was applied

Shoulder massage group

Eligibility Criteria

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

You may qualify if:

  • Participants were expected to be able to speak Turkish and have normal verbal communication skills.
  • They were required to possess normal cognitive abilities and have no psychiatric diagnoses.
  • Patients aged between 18 and 70 years.
  • Patients undergoing general anesthesia.
  • Patients who voluntarily agree to participate in the research

You may not qualify if:

  • Patients receiving epidural analgesia post-surgery.
  • Patients whose laparoscopic cholecystectomy (LC) procedure was converted to an open cholecystectomy during the operation.
  • Patients experiencing postoperative confusion, requiring intensive care, or developing secondary complications that impair their ability to respond to questions accurately.
  • Patients who do not report shoulder pain following surgery.
  • Patients in a catabolic state, those aged 70 years or older, individuals with chronic pain or opioid use, and those experiencing severe postoperative symptoms such as excessive nausea, vomiting, bleeding, or infection.
  • Patients with surgical drains (e.g., Hemovac) may negatively influence pain levels and sleep quality, thereby interfering with the effectiveness of the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun Universitesi

Giresun, Piraziz, 28000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

Control GroupsTherapeutic Touch

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2025

First Posted

August 1, 2025

Study Start

April 17, 2024

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations