Hand MassageNCT07296679
The Effect of Hand Massage on Anxiety and Comfort of Bariatric Surgery Patients: A Randomised Controlled Trial
A study testing Experimental Group in people with Hand Massage and Anxiety, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of hand massage on anxiety and comfort levels in bariatric surgery patients. Read more about this study
- Who is it for?
- Ages 35 to 53 years
- Conditions the study is for
- Hand Massage, Anxiety
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2024to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 53 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to determine the effect of hand massage on anxiety and comfort levels in bariatric surgery patients.
Read the 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).
- Conditions
- Hand Massage, Anxiety
- Being tested
- Experimental Group
- Keywords
- Hand massage, anxiety, comfort, nursing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
Also called Procedure/Surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two weeks
Secondary outcomes (1)
General Comfort Scale-Short Form (SGCQ)
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.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start14 Apr 2024
- Primary completion20 Mar 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand MassageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomised controlled experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Güneş, Firat University
- Investigators
- DİLEK GÜNEŞ, Principal investigator, FIRAT ÜNİVERSİTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296679
- Sponsor's protocol ID
- FiratOU
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Massage on Anxiety and Comfort of Bariatric Surgery Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07296679
- Acronym / sponsor ID
- FiratOU
- Conditions
- Hand Massage, Anxiety
- Keywords
- Hand massage, anxiety, comfort, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to determine the effect of hand massage on anxiety and comfort levels in bariatric surgery patients.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This randomised controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental GroupUpon 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. |
| 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. |
Who may qualify
- Ages
- 35 to 53 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupAlso: Procedure/SurgeryUpon 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 |
Primary outcome
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.
1 secondary outcome
General Comfort Scale-Short Form (SGCQ)
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DİLEK GÜNEŞ principal investigator
FIRAT ÜNİVERSİTESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Hand Massage and Anxiety, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Inventory (STAI) (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.