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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Stress Ball
  Squeezing a soft stress ball for 15 minutes during surgery.
• Поведенческое Hand Massage
  A 10-minute hand massage applied by a researcher using baby oil.

Первичные конечные точки

• Anxiety Level [Срок оценки: Pre-operatively (baseline) and 10 minutes post-operatively.]
• Pain Severity [Срок оценки: 10 minutes post-operatively.]

Вторичные конечные точки (5)

• Systolic Blood Pressure [Срок оценки: 10 minutes post-operatively]
• Diastolic Blood Pressure [Срок оценки: 10 minutes post-operatively]
• Heart Rate [Срок оценки: 10 minutes post-operatively]
• Respiratory Rate [Срок оценки: 10 minutes post-operatively]
• Oxygen Saturation Levels [Срок оценки: 10 minutes post-operatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital — Erzincan

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07522034 · 2025-21/06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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