Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital
Erzincan, Turkey (Türkiye)
NCT Number: NCT07522034
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Erzincan, Turkey (Türkiye)
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Squeezing a soft stress ball for 15 minutes during surgery.
A 10-minute hand massage applied by a researcher using baby oil.
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).
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).
Time frame: 10 minutes post-operatively
Systolic blood pressure will be measured and recorded using a Physiological Parameters Evaluation Form.
Time frame: 10 minutes post-operatively
Diastolic blood pressure will be measured and recorded using a Physiological Parameters Evaluation Form.
Time frame: 10 minutes post-operatively
Heart rate will be measured and recorded using a Physiological Parameters Evaluation Form.
Time frame: 10 minutes post-operatively
Respiratory rate will be measured and recorded using a Physiological Parameters Evaluation Form.
Time frame: 10 minutes post-operatively
Oxygen saturation levels will be measured and recorded using a Physiological Parameters Evaluation Form.
Contact information is provided by the study sponsor or research team.
Mehmet Gunay Uyar
Other
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
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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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