NCT07296679

Brief Summary

This study was conducted to determine the effect of hand massage on anxiety and comfort levels in bariatric surgery patients.

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 Apr 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

Study Start

First participant enrolled

April 14, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
Last Updated

December 22, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

November 25, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

Hand massageanxietycomfortnursing

Outcome Measures

Primary Outcomes (1)

  • State Anxiety Inventory (STAI)

    The scale was developed by Spielberger et al. Reliability and validity were carried out by Öner and Le Compte. The scale consists of two sub-units that measure anxiety separately, but in this study, the state anxiety scale that the individual feels indirectly from the stressful situation will be used. It is a 4-point Likert-type scale consisting of 20 items and short statements. The total score obtained from the scale varies between 20 and 80, and a high score indicates a high level of anxiety.

    two weeks

Secondary Outcomes (1)

  • General Comfort Scale-Short Form (SGCQ)

    two weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Upon admission to the General Surgery clinic, patients were apprised of the study's objective, and their written and verbal agreement was acquired. Prior to the preoperative hand massage, the Patient Information Form, State-Trait Anxiety Inventory (STAI), and Short Form General Comfort Questionnaire (SGCQ) were administered to the patients in the general surgery clinic's patient room via face-to-face interviews. The patient rooms were single-occupancy, naturally lit, windowed, calm, quiet, and located within the clinic. Immediately before surgery, classic massage techniques including petrissage, friction, and kneading were applied to both hands for 10 minutes using baby oil on the palms, backs of the hands, and fingers. The hand massage was performed while the patient was in bed. The application lasted approximately 25 minutes. After the hand massage, State-Trait Anxiety Inventory (STAI) and General Comfort Scale-Short Form (SGCQ) were administered to the patients as post-test.

Other: Experimental Group

Control group

NO INTERVENTION

No intervention other than the clinic protocol was applied to this group. In the control group, Patient Information Form, State-Trait Anxiety Inventory (STAI), General Comfort Scale-Short Form (SGCQ) were administered as pre-test before the operation. Just before the operation, State-Trait Anxiety Inventory (STAI) and General Comfort Scale-Short Form were administered as post-test.

Interventions

Upon admission to the General Surgery clinic, patients were apprised of the study's objective, and their written and verbal agreement was acquired. Prior to the preoperative hand massage, the Patient Information Form, State-Trait Anxiety Inventory (STAI), and Short Form General Comfort Questionnaire (SGCQ) were administered to the patients in the general surgery clinic's patient room via face-to-face interviews. The patient rooms were single-occupancy, naturally lit, windowed, calm, quiet, and located within the clinic. Immediately before surgery, classic massage techniques including petrissage, friction, and kneading were applied to both hands for 10 minutes using baby oil on the palms, backs of the hands, and fingers. The hand massage was performed while the patient was in bed. The application lasted approximately 25 minutes. After the hand massage, State-Trait Anxiety Inventory (STAI) and General Comfort Scale-Short Form (SGCQ) were administered to the patients as post-test.

Also known as: Procedure/Surgery
Experimental group

Eligibility Criteria

Age35 Years - 53 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 or older
  • Not having a speech problem or hearing loss
  • Not having any condition that would reduce comprehension and understanding abilities
  • Agreeing to participate in the study
  • Having a body mass index (BMI) ≥ 30.

You may not qualify if:

  • Having compromised tissue and skin on the forearm or hands (e.g., wounds, eczema, inflammation, phlebitis, arthritis, and rashes)
  • Having an intravenous catheter in the back of the hand.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firat Universty

Elâzığ, 23119, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • DİLEK GÜNEŞ

    FIRAT ÜNİVERSİTESİ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant) By drawing lots, the first set was chosen to correspond to the experimental group and the second set to correspond to the control group for the two groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This randomised controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 22, 2025

Study Start

April 14, 2024

Primary Completion

March 20, 2025

Study Completion

November 20, 2025

Last Updated

December 22, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations