NCT07522034

Brief Summary

The purpose of this study is to evaluate the effects of hand massage and stress ball interventions on anxiety, pain, and physiological parameters in patients undergoing eye surgery. Because eye surgeries are typically performed under local or topical anesthesia, patients remain conscious, which can lead to increased anxiety and pain. This randomized controlled trial aims to find safe, non-pharmacological, and easily applicable nursing methods to improve patient comfort. Adult patients scheduled for eye surgery will be randomly assigned to one of three groups: Hand Massage Group: Patients will receive a gentle hand massage by a trained researcher for 5 minutes on each hand (10 minutes total) during the surgery. Stress Ball Group: Patients will rhythmically squeeze and release a soft stress ball for 5 seconds at a time, for a total of 15 minutes during the surgery. Control Group: Patients will receive standard routine care without any additional interventions. Researchers will measure the patients' vital signs (blood pressure, heart rate, respiratory rate, and oxygen saturation), as well as their self-reported anxiety and pain levels, to compare the effectiveness of these interventions.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
174

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
15mo left

Started May 2026

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Aug 2027

First Submitted

Initial submission to the registry

March 28, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

March 28, 2026

Last Update Submit

April 3, 2026

Conditions

Ophthalmologic Surgical ProcedureAnxietyPain

Keywords

Hand MassageStress BallEye SurgeryAnxietyPainNursing InterventionPhysiological Parameters

Outcome Measures

Primary Outcomes (2)

  • Anxiety Level

    Assessed using the Visual Analog Scale (VAS) for Anxiety. The scale is a 10 cm horizontal line ranging from 0 to 10. A score of 0 indicates "No anxiety" and a score of 10 indicates "Extreme anxiety". Higher scores indicate a worse outcome (higher anxiety levels).

    Pre-operatively (baseline) and 10 minutes post-operatively.

  • Pain Severity

    Assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 represents "No pain" and 10 represents "Unbearable pain". Higher scores indicate a worse outcome (more severe pain).

    10 minutes post-operatively.

Secondary Outcomes (5)

  • Systolic Blood Pressure

    10 minutes post-operatively

  • Diastolic Blood Pressure

    10 minutes post-operatively

  • Heart Rate

    10 minutes post-operatively

  • Respiratory Rate

    10 minutes post-operatively

  • Oxygen Saturation Levels

    10 minutes post-operatively

Study Arms (3)

Stress Ball

EXPERIMENTAL

Patients in this group will perform a squeeze-and-release exercise using a soft, latex-free stress ball for 5 seconds at rhythmic intervals over a 15-minute period during the eye surgery.

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.

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.

Interventions

Stress BallBEHAVIORAL

Squeezing a soft stress ball for 15 minutes during surgery.

Stress Ball
Hand MassageBEHAVIORAL

A 10-minute hand massage applied by a researcher using baby oil.

Hand Massage

Eligibility Criteria

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

You may qualify if:

  • Being 18 years of age or older.
  • Undergoing eye surgery under topical or local anesthesia.
  • Being conscious, able to communicate, and having the cognitive capacity to answer questions.
  • Having no communication barriers (e.g., hearing, speech, or language problems).
  • Having no physical barriers or limitations that would prevent hand massage or stress ball application.
  • Volunteering to participate in the study.
  • Being able to read and understand Turkish.

You may not qualify if:

  • Transitioning to general anesthesia during the eye surgery.
  • Having a history of severe cardiovascular, neurological, or psychiatric diseases.
  • Experiencing any discomfort during the hand massage or stress ball application.
  • Cancellation of the surgery during the research process or the participant requesting to withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital

Erzincan, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 40399154RESULT

  • 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.

    PMID: 38775768RESULT

  • 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.

    PMID: 31551136RESULT

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mehmet Günay UYAR, PhD

CONTACT

+90 554 348 83 91mehmet.uyar@erzincan.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 28, 2026

First Posted

April 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)