Effects of Stress Ball and Hand Massage on Vital Signs, Anxiety, and Pain During Eye Surgery

April 3, 2026 updated by: Mehmet Gunay Uyar

The Effect of Stress Ball and Hand Massage Interventions Applied During Eye Surgery on Patients' Physiological Parameters, Anxiety, and Pain Levels: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

While eye surgeries are effective in restoring visual function, they are predominantly performed under local or topical anesthesia. Because patients remain conscious during the procedure, they frequently experience increased anxiety and pain, which can negatively affect their physiological parameters, reduce compliance with the surgical process, and potentially increase the risk of complications. Pharmacological methods for managing anxiety and pain carry risks of drug interactions and side effects, particularly in the elderly population. Therefore, non-pharmacological nursing interventions such as hand massage (which promotes relaxation through tactile stimulation) and stress ball squeezing (which reduces pain and anxiety perception through cognitive distraction) are gaining importance as safe, low-cost, and non-invasive alternatives.

This study will be conducted at the ophthalmology clinic and operating room of Binali Yıldırım University Mengücek Gazi Training and Research Hospital. Participants will be assigned to one of three groups using computer-assisted block randomization to ensure homogeneity.

The study procedure follows three main phases:

  1. Pre-operative Phase: Following informed consent, patients' baseline anxiety levels are measured. A brief training is provided to the intervention groups regarding the procedures they will perform during surgery.
  2. Intra-operative Phase: Interventions are applied under the supervision of a researcher. For the hand massage group, a trained researcher applies a massage using hypoallergenic baby oil for 5 minutes on each hand (10 minutes total). For the stress ball group, patients squeeze a soft, latex-free ball for 5 seconds at rhythmic intervals over a 15-minute period. The control group receives standard intraoperative care without these specific interventions.
  3. Post-operative Phase: Ten minutes after the patients are transferred back to their rooms, researchers collect data on anxiety, pain, and physiological parameters (systolic/diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation).

Data collection is conducted face-to-face using a Personal Information Form, a Physiological Parameters Evaluation Form, a Numeric Rating Scale (NRS) for pain, and a Visual Analog Scale (VAS) for anxiety.

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • 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 Contact

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stress Ball
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
Squeezing a soft stress ball for 15 minutes during surgery.
Experimental: Hand Massage
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
A 10-minute hand massage applied by a researcher using baby oil.
No Intervention: Control
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Level
Time Frame: Pre-operatively (baseline) and 10 minutes post-operatively.
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
Time Frame: 10 minutes post-operatively.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: 10 minutes post-operatively
Systolic blood pressure will be measured and recorded using a Physiological Parameters Evaluation Form.
10 minutes post-operatively
Diastolic Blood Pressure
Time Frame: 10 minutes post-operatively
Diastolic blood pressure will be measured and recorded using a Physiological Parameters Evaluation Form.
10 minutes post-operatively
Heart Rate
Time Frame: 10 minutes post-operatively
Heart rate will be measured and recorded using a Physiological Parameters Evaluation Form.
10 minutes post-operatively
Respiratory Rate
Time Frame: 10 minutes post-operatively
Respiratory rate will be measured and recorded using a Physiological Parameters Evaluation Form.
10 minutes post-operatively
Oxygen Saturation Levels
Time Frame: 10 minutes post-operatively
Oxygen saturation levels will be measured and recorded using a Physiological Parameters Evaluation Form.
10 minutes post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mehmet Gunay Uyar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-21/06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

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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