Ireland
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Recruiting Not applicable

The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety

NCT07108192 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-10-08
Last updated
2026-02-06

Condition(s) studied

Cataract Surgery

Investigational drug(s) / intervention(s)

Hand HoldingStress BallControl Group

Hand Holding: Hand holding intervention will be performed by the researcher. Before cataract surgery, the researcher will sit in a chair next to the patient and warm his/her hands to a level that does not disturb the patient. 1-2 minutes before cataract surgery, the researcher will hold the patient's hand without gloves, with one hand, with moderate pressure, without rubbing or squeezing it uncomfortably. The hand holding intervention will continue until the cataract surgery is completed

Stress Ball: According to the randomization, the patient in the stress ball group will first be taught the use of stress balls face to face by the researcher. The researcher will place a round, medium-hard, high-quality stress ball of the same brand in the patient's active hand 1-2 minutes before the cataract surgery is started. The patient will be asked to squeeze and relax the stress ball by counting to 5 during cataract surgery. After squeezing the stress ball, he/she should count to 5 and then loosen it. The patient will be asked to continue this process until the cataract surgery is completed.

Control Group: Patients who did not receive any intervention other than standard treatment and care during cataract surgery were defined as the control group.

Study summary

Cataract surgery is currently primarily performed with topical anesthesia. Although topical anesthesia provides many benefits for patients, they may experience pain, anxiety and discomfort during surgery. It has been reported that increased pain and anxiety during surgery may decrease patient cooperation and satisfaction, making surgery more difficult. In this context, in addition to medical interventions, non-pharmacologic methods are recommended to manage pain and anxiety during surgery. Non-pharmacological methods are reported to be simple, effective and cost-effective. In this context, studies have shown that stress ball application and hand holding are effective strategies for the control of pain and anxiety in patients.

According to this information, the aim of this study was to evaluate the effect of stress ball application and hand holding method used during cataract surgery on patients' pain and anxiety.

Another aim of the study was to determine the effects of stress ball application and hand holding method on patients' satisfaction levels and vital signs.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18 years and over * Can understand and speak Turkish * Clear consciousness, person, place and time oriented * No hearing and perception problems * Does not have any mental or neurological disorders that may affect communication (Alzheimer's, dementia, etc.) * First time cataract surgery * Those without any psychiatric diagnosis/ treatment (antidepressants, anxiolytics, sedatives, etc.) * No physical problems in squeezing the stress ball (muscle, joint problems, etc.) * No analgesic or anesthetic medication 24 hours before the procedure * Individuals who agree to participate in the study will be included in the study Exclusion Criteria: * Conversion of topical anesthesia to general anesthesia during surgery * A different story of eye surgery * Hearing, speech, physical or mental disability * Pregnancy or possible pregnancy * Those with malignancy * Taking an analgesic medication at least 24 hours before the procedure * People with chronic pain * History of incomplete or canceled cataract procedures * Hypertension in the patient (\>160/100 mmHg) * Suppurative/infective/inflammatory skin condition of the hands * Hypersensitivity to touch * Patients with contact-transmitted diseases * Being uncomfortable with hand-holding, * In case of need for emergency intervention by a physician during or immediately after the procedure * Failure to perform the stress ball application in accordance with the instruction * Pre-existing neuropathy (muscle joint problem, stroke, etc.) * Complications during cataract surgery * Those who want to leave the study voluntarily * Termination of the procedure due to deterioration of the patient's general condition during the procedure * Failure to carry out intervention practices in accordance with the determined protocol (Dropping the stress ball during the procedure, etc.)

Primary outcome measure(s)

  • Anxiety levels — Anxiety levels of the patients will be evaluated in 2 stages, 15 minutes before surgery and 15 minutes after the surgery is completed.
    Anxiety level of the patients will be evaluated with State Anxiety Inventory Short Version. The short form of the inventory was developed by Zsido and colleagues and adapted to the Turkish population. The form is a 4-point Likert-type inventory consisting of a total of 5 items. Individuals who score 10 and higher on the State Anxiety Inventory Short Version are considered clinically anxious.
  • Pain levels — Patients' pain levels will be evaluated in 2 stages: intraoperatively and 15 minutes after the operation is completed
    The pain level of the patients will be evaluated by Visual Analog Scale (VAS). Their values range from 0-10. Absence of pain is defined as "0 points" and unbearable pain is defined as "10 points".

Trial sites (1)

FacilityCityRegionStatus
Yenikent State Hospital Sakarya Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07108192 on ClinicalTrials.gov ↗ ← All trials in Turkey