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
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mehmet Gunay Uyar
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Anxiety Level
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Stress Ball (Behavioral)
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.
干预措施: Hand Massage (Behavioral)
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.
结局指标
主要结局
Anxiety Level
时间窗: 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
时间窗: 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).
次要结局
- Systolic Blood Pressure(10 minutes post-operatively)
- Diastolic Blood Pressure(10 minutes post-operatively)
- Heart Rate(10 minutes post-operatively)
- Respiratory Rate(10 minutes post-operatively)
- Oxygen Saturation Levels(10 minutes post-operatively)
研究者
Mehmet Gunay Uyar
Assistant Professor
Ataturk University