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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07522034
Enrollment
174
Registered
2026-04-13
Start date
2026-05-01
Completion date
2027-08-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Ophthalmologic Surgical Procedure, Pain

Keywords

Hand Massage, Stress Ball, Eye Surgery, Anxiety, Pain, Nursing Intervention, Physiological Parameters

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.

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.

Interventions

BEHAVIORALStress Ball

Squeezing a soft stress ball for 15 minutes during surgery.

BEHAVIORALHand Massage

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

Sponsors

Mehmet Gunay Uyar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Anxiety LevelPre-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).
Pain Severity10 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).

Secondary

MeasureTime frameDescription
Systolic Blood Pressure10 minutes post-operativelySystolic blood pressure will be measured and recorded using a Physiological Parameters Evaluation Form.
Diastolic Blood Pressure10 minutes post-operativelyDiastolic blood pressure will be measured and recorded using a Physiological Parameters Evaluation Form.
Heart Rate10 minutes post-operativelyHeart rate will be measured and recorded using a Physiological Parameters Evaluation Form.
Respiratory Rate10 minutes post-operativelyRespiratory rate will be measured and recorded using a Physiological Parameters Evaluation Form.
Oxygen Saturation Levels10 minutes post-operativelyOxygen saturation levels will be measured and recorded using a Physiological Parameters Evaluation Form.

Countries

Turkey (Türkiye)

Contacts

CONTACTMehmet Günay UYAR, PhD
mehmet.uyar@erzincan.edu.tr+90 554 348 83 91

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026