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NCT Number: NCT07522034

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital

Erzincan, Turkey (Türkiye)

Location contact

Mehmet Günay UYAR, PhD

CONTACT

[email protected]

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

stress ball

Behavioral

Squeezing a soft stress ball for 15 minutes during surgery.

Hand Massage

Behavioral

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

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Systolic Blood Pressure

    Time frame: 10 minutes post-operatively

    Systolic blood pressure will be measured and recorded using a Physiological Parameters Evaluation Form.

  2. Diastolic Blood Pressure

    Time frame: 10 minutes post-operatively

    Diastolic blood pressure will be measured and recorded using a Physiological Parameters Evaluation Form.

  3. Heart Rate

    Time frame: 10 minutes post-operatively

    Heart rate will be measured and recorded using a Physiological Parameters Evaluation Form.

  4. Respiratory Rate

    Time frame: 10 minutes post-operatively

    Respiratory rate will be measured and recorded using a Physiological Parameters Evaluation Form.

  5. Oxygen Saturation Levels

    Time frame: 10 minutes post-operatively

    Oxygen saturation levels will be measured and recorded using a Physiological Parameters Evaluation Form.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Günay UYAR, PhD

CONTACT

[email protected]

+90 554 348 83 91

Sponsors and collaborators

Lead sponsor

Mehmet Gunay Uyar

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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