AnxietyNCT07522034

Effects of Hand Massage and Stress Ball Interventions During Eyelid Surgery

A study testing Stress Ball and Hand Massage in people with Anxiety and Ophthalmologic Surgical Procedure, run by Mehmet Gunay Uyar at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anxiety, Ophthalmologic Surgical Procedure, Pain
What is being tested?: Stress Ball and Hand Massage
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Apr 2026to 25 Sep 2026
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Being 18 years of age or older.
Undergoing eyelid surgery under topical or local anesthesia.
Being conscious and able to communicate.
Being able to understand Turkish.
Having no physical limitation that would prevent hand massage or stress ball use.
Volunteering to participate and providing written informed consent.

Who cannot join

Conversion from topical or local anesthesia to general anesthesia.
Having a serious cardiovascular, respiratory, neurological, or psychiatric disorder.
Experiencing discomfort during the intervention that required discontinuation.
Cancellation of the scheduled surgery.
Requesting withdrawal from the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital
Erzincan

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Intraoperative Hand Massage and Stress Ball Interventions on Anxiety, Pain, and Physiological Parameters During Eyelid Surgery: A Randomized Controlled Trial

This randomized, single-center, three-arm, parallel-group trial evaluated the effects of intraoperative hand massage and stress ball use on anxiety, early postoperative pain, and physiological parameters in adults undergoing eyelid surgery under local or topical anesthesia. Participants were randomly assigned in a 1:1:1 ratio to the hand massage, stress ball, or control group. The hand massage group received a 10-minute massage administered by a trained researcher using hypoallergenic baby oil, with 5 minutes applied to each hand. The stress ball group squeezed and released a soft, latex-free stress ball at 5-second intervals for 10 minutes during surgery. The control group received routine intraoperative care without an additional study intervention. The primary outcome was postoperative state anxiety. Secondary outcomes were visual analog scale anxiety, postoperative pain, blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation.

Read the detailed description

Eyelid surgery performed under local or topical anesthesia requires patients to remain conscious during the procedure and may be accompanied by anxiety and discomfort. Non-pharmacological nursing interventions may support routine perioperative care without adding medication-related burden. This study compared intraoperative hand massage and stress ball use with routine care. State anxiety was assessed before surgery and 20 minutes after surgery. Visual analog scale anxiety was assessed on the operating table before the intervention, 10 minutes after the intervention, and at the end of surgery. Pain was assessed 20 minutes after surgery. Physiological parameters were measured at prespecified perioperative time points.

Conditions: Anxiety, Ophthalmologic Surgical Procedure, Pain
Being tested: Stress Ball, Hand Massage
Keywords: Hand Massage, Stress Ball, Eye Surgery, Anxiety, Pain, Nursing Intervention, Physiological Parameters
Medical subject headings: Anxiety Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stress BallBehavioural
Squeezing and releasing a soft, latex-free stress ball at 5-second intervals for 10 minutes during eyelid surgery.
Hand MassageBehavioural
A 10-minute hand massage applied by a researcher using baby oil.

Study groups in NCT07522034
Study group	Role	What they receive
Stress Ball	Experimental	Patients in this group were instructed to squeeze and release a soft, latex-free stress ball at 5-second intervals for 10 minutes during eyelid surgery. Receives: Behavioral: Stress Ball
Hand Massage	Experimental	Patients in this group will receive a hand massage applied by a trained researcher using hypoallergenic baby oil. The massage will be applied for 5 minutes on each hand, for a total of 10 minutes during the eye surgery. Receives: Behavioral: Hand Massage
Control	No intervention	Patients in the control group will receive standard routine intraoperative care. No additional research-specific interventions (such as a stress ball or hand massage) will be applied to this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative State Anxiety Level
Postoperative state anxiety was assessed using the 20-item State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-S). Total scores range from 20 to 80, with higher scores indicating higher state anxiety. The primary endpoint was assessed 20 minutes after surgery. State anxiety was also assessed before surgery to evaluate change over time.
Measured: 20 minutes after surgery

Secondary outcomes (7)

Systolic Blood Pressure
Systolic blood pressure was measured in mmHg and recorded using a Physiological Parameters Evaluation Form.
Measured: Preoperative baseline, 10 minutes after the intervention, and 20 minutes after surgery
Diastolic Blood Pressure
Diastolic blood pressure was measured in mmHg and recorded using a Physiological Parameters Evaluation Form.
Measured: Preoperative baseline, 10 minutes after the intervention, and 20 minutes after surgery
Heart Rate
Heart rate was measured in beats per minute and recorded using a Physiological Parameters Evaluation Form.
Measured: Preoperative baseline, on the operating table before the intervention, 10 minutes after the intervention, at the end of surgery, and 20 minutes after surgery
Respiratory Rate
Respiratory rate was measured in breaths per minute and recorded using a Physiological Parameters Evaluation Form.
Measured: Preoperative baseline, 10 minutes after the intervention, and 20 minutes after surgery
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) was measured as a percentage and recorded using a Physiological Parameters Evaluation Form.
Measured: Preoperative baseline, 10 minutes after the intervention, and 20 minutes after surgery
Anxiety Level-VAS
Anxiety was assessed using a 10-cm Visual Analog Scale for Anxiety ranging from 0 ("no anxiety") to 10 ("extreme anxiety"). Higher scores indicate greater anxiety.
Measured: On the operating table before the intervention, 10 minutes after the intervention, and at the end of surgery
Postoperative Pain Intensity
Pain intensity was assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 ("no pain") to 10 ("unbearable pain"). Higher scores indicate greater pain intensity.
Measured: 20 minutes after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202625 Sep 2026

First posted13 Apr 2026
Study start15 Apr 2026
Primary completion25 Sep 2026
Study completion25 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07522034
Sponsor's protocol ID: 2025-21/06
Status last verified: Oct 2026
First submitted: 28 Mar 2026
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be shared because the informed consent obtained from the participants and the ethics committee approval do not cover the sharing of raw, individual-level data with third parties. Only aggregated data will be presented in publications to strictly maintain patient privacy.

Publications

Yenigun SC, Demir Korkmaz F. The Effects of Stress Ball Practice on Patient Anxiety, Pain and Vital Signs During Cataract Surgery: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Oct;26(5):592-599. doi: 10.1016/j.pmn.2025.04.009. Epub 2025 May 20.
PubMed 40399154
Dastan N, Sezer Efe Y, Erkilic K. The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters. J Perianesth Nurs. 2024 Oct;39(5):831-838. doi: 10.1016/j.jopan.2023.12.018. Epub 2024 May 22.
PubMed 38775768
Cavdar AU, Yilmaz E, Baydur H. The Effect of Hand Massage Before Cataract Surgery on Patient Anxiety and Comfort: A Randomized Controlled Study. J Perianesth Nurs. 2020 Feb;35(1):54-59. doi: 10.1016/j.jopan.2019.06.012. Epub 2019 Sep 21.
PubMed 31551136

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Intraoperative Hand Massage and Stress Ball Interventions on Anxiety, Pain, and Physiological Parameters During Eyelid Surgery: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07522034
Acronym / sponsor ID: 2025-21/06
Conditions: Anxiety, Ophthalmologic Surgical Procedure, Pain
Keywords: Hand Massage, Stress Ball, Eye Surgery, Anxiety, Pain, Nursing Intervention, Physiological Parameters
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Mehmet Gunay UyarUniversity, hospital or other
Study start: 15 Apr 2026 (actual)
Primary completion: 25 Sep 2026 (actual)
Study completion: 25 Sep 2026 (actual)
First posted: 13 Apr 2026 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Stress Ball	Experimental	Behavioral: Stress BallPatients in this group were instructed to squeeze and release a soft, latex-free stress ball at 5-second intervals for 10 minutes during eyelid surgery.
Hand Massage	Experimental	Behavioral: Hand MassagePatients in this group will receive a hand massage applied by a trained researcher using hypoallergenic baby oil. The massage will be applied for 5 minutes on each hand, for a total of 10 minutes during the eye surgery.
Control	No intervention	–Patients in the control group will receive standard routine intraoperative care. No additional research-specific interventions (such as a stress ball or hand massage) will be applied to this group.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Being 18 years of age or older.
Undergoing eyelid surgery under topical or local anesthesia.
Being conscious and able to communicate.
Being able to understand Turkish.
Having no physical limitation that would prevent hand massage or stress ball use.

Key exclusion criteria (5 listed)

Conversion from topical or local anesthesia to general anesthesia.
Having a serious cardiovascular, respiratory, neurological, or psychiatric disorder.
Experiencing discomfort during the intervention that required discontinuation.
Cancellation of the scheduled surgery.
Requesting withdrawal from the study.

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
Stress BallSqueezing and releasing a soft, latex-free stress ball at 5-second intervals for 10 minutes during eyelid surgery.	Behavioural	Stress Ball
Hand MassageA 10-minute hand massage applied by a researcher using baby oil.	Behavioural	Hand Massage

Primary outcome

Postoperative State Anxiety Level
Time frame: 20 minutes after surgery
Postoperative state anxiety was assessed using the 20-item State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-S). Total scores range from 20 to 80, with higher scores indicating higher state anxiety. The primary endpoint was assessed 20 minutes after surgery. State anxiety was also assessed before surgery to evaluate change over time.

7 secondary outcomes

Systolic Blood Pressure
Time frame: Preoperative baseline, 10 minutes after the intervention, and 20 minutes after surgery
Diastolic Blood Pressure
Time frame: Preoperative baseline, 10 minutes after the intervention, and 20 minutes after surgery
Heart Rate
Time frame: Preoperative baseline, on the operating table before the intervention, 10 minutes after the intervention, at the end of surgery, and 20 minutes after surgery
Respiratory Rate
Time frame: Preoperative baseline, 10 minutes after the intervention, and 20 minutes after surgery
Peripheral Oxygen Saturation (SpO₂)
Time frame: Preoperative baseline, 10 minutes after the intervention, and 20 minutes after surgery
Anxiety Level-VAS
Time frame: On the operating table before the intervention, 10 minutes after the intervention, and at the end of surgery
Postoperative Pain Intensity
Time frame: 20 minutes after surgery

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 23 Oct 2026.
Background: PubMed 40399154Yenigun SC, Demir Korkmaz F. The Effects of Stress Ball Practice on Patient Anxiety, Pain and Vital Signs During Cataract Surgery: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Oct;26(5):592-599. doi: 10.1016/j.pmn.2025.04.009. Epub 2025 May 20.
Background: PubMed 38775768Dastan N, Sezer Efe Y, Erkilic K. The Effect of Hand Massage Applied Before Cataract Surgery on Anxiety, Surgical Fear, Pain and Physiological Parameters. J Perianesth Nurs. 2024 Oct;39(5):831-838. doi: 10.1016/j.jopan.2023.12.018. Epub 2024 May 22.
Background: PubMed 31551136Cavdar AU, Yilmaz E, Baydur H. The Effect of Hand Massage Before Cataract Surgery on Patient Anxiety and Comfort: A Randomized Controlled Study. J Perianesth Nurs. 2020 Feb;35(1):54-59. doi: 10.1016/j.jopan.2019.06.012. Epub 2019 Sep 21.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the informed consent obtained from the participants and the ethics committee approval do not cover the sharing of raw, individual-level data with third parties. Only aggregated data will be presented in publications to strictly maintain patient privacy.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stress Ball and Hand Massage in people with Anxiety and Ophthalmologic Surgical Procedure, run by Mehmet Gunay Uyar 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 6 inclusion and 5 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 23 Oct 2026. 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?

Postoperative State Anxiety Level (time frame: 20 minutes after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07522034, which also lists 3 linked publications.

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 23 Oct 2026.