Effects of Hand Massage and Stress Ball Interventions During Eyelid Surgery

NCT07522034 — Not applicable, Completed, 174 participants, Mehmet Gunay Uyar

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

RegistryNCT07522034
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment174 (Actual)
SponsorMehmet Gunay Uyar (Other)
ConditionsAnxiety, Ophthalmologic Surgical Procedure, Pain
InterventionsStress Ball, Hand Massage (Behavioral)
Datesstart 2026-04-15, primary completion 2026-09-25, completion 2026-09-25, first posted 2026-04-13, last updated 2026-09-30
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Anxiety All trials for Ophthalmologic Surgical Procedure All trials of Stress Ball All trials of Hand Massage

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Stress BallExperimentalBehavioral: Stress BallPatients 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.
Hand MassageExperimentalBehavioral: 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.
ControlNo interventionPatients 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.
  • 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.

+Outcome measures

Primary outcomes

  • Anxiety Level [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).
  • Pain Severity [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

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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Erzincan Binali Yildirim University Mengucek Gazi Training and Research HospitalErzincanTurkey (Türkiye)

+Publications

  • Results publication: 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 40399154
  • Results publication: 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 38775768
  • Results publication: 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 31551136