The Effect of Hand Massage on Anxiety and Comfort of Bariatric Surgery Patients: A Randomised Controlled Trial

December 8, 2025 updated by: Dilek Güneş, Firat University
This study was conducted to determine the effect of hand massage on anxiety and comfort levels in bariatric surgery patients.

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 study was conducted to determine the effect of hand massage on anxiety and comfort levels in bariatric surgery patients. This randomised controlled trial was conducted in the General Surgery Clinic of a University Hospital in eastern Turkey with all adult patients undergoing bariatric surgery between September 2024 - March 2025. The sample consisted of 90 randomised patients who received hand massage and received only routine care. Data were collected using the Patient Information Form, State-Trait Anxiety Inventory (STAI), General Comfort Scale-Short Form (SGCQ).

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

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

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

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: Prevention
  • 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: Experimental group

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
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 Names:
  • Procedure/Surgery
No Intervention: Control group
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.

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
State Anxiety Inventory (STAI)
Time Frame: two weeks
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 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
General Comfort Scale-Short Form (SGCQ)
Time Frame: two weeks
It was developed by Kolcaba to determine the comfort requirements of the individual. The Turkish validity and reliability study of the scale was conducted by Sarıtaş et al. In the evaluation of the scale, negative items (items 2, 3, 7, 9, 11, 18, 20, 21, 23, 24, 27) are reverse coded and summed. This 6-point Likert-type scale consisting of 28 items consists of three sub-dimensions: refreshment (1-9 items), relaxation (10-18 items) and superiority (19-28 items). The lowest score that can be obtained from the scale is 28 and the highest score is 168. As the score obtained from the scale decreases, it indicates that the comfort level of the individual is low.
two weeks

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.
Firat University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: DİLEK GÜNEŞ, FIRAT ÜNİVERSİTESİ

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.
April 14, 2024

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.
March 20, 2025

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.
November 20, 2025

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).
November 25, 2025

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.
December 8, 2025

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.
December 22, 2025

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.
December 22, 2025

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.
December 8, 2025

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.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • FiratOU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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