Actively Recruiting
The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety During Cataract Surgery: A Randomized Controlled Trial
Led by Sakarya University · Updated on 2026-02-06
108
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Cataract surgery is a common procedure performed under topical anesthesia to treat visual impairment. Although topical anesthesia is widely used to avoid serious complications, patients may still experience pain, anxiety, and discomfort during the operation. These factors can reduce patient cooperation and satisfaction, potentially complicating the surgery. Researchers are studying non-drug methods like stress ball use and hand holding to help manage pain and anxiety during cataract surgery, aiming to improve patient comfort and vital signs. The study compares three groups of patients undergoing cataract surgery: one using a stress ball, one receiving hand holding, and a control group receiving standard care without additional interventions. Stress ball users will be guided to squeeze and relax the ball throughout surgery, while hand holding involves the researcher holding the patient's hand with moderate pressure from shortly before until the end of the surgery. These simple, cost-effective methods are being evaluated for their effects on pain, anxiety, satisfaction, and vital signs. Participants will have anxiety and pain assessed before, during, and after surgery, with satisfaction measured 15 minutes post-operation. Vital signs including blood pressure, pulse rate, respiratory rate, and oxygen saturation will be monitored before and after the procedure. The study will measure changes in these outcomes to evaluate the impact of stress ball use and hand holding during cataract surgery. Total participation includes these assessments around the time of surgery.
CONDITIONS
Brief Title
The Effect of Hand Holding and Stress Ball Intervention on Pain and Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years and over
- Can understand and speak Turkish
- Clear consciousness, person, place and time oriented
- No hearing and perception problems
- No mental or neurological disorders affecting communication (e.g., Alzheimer's, dementia)
- First time cataract surgery
- No psychiatric diagnosis or treatment (e.g., antidepressants, anxiolytics, sedatives)
- No physical problems that prevent squeezing a stress ball (e.g., muscle or joint problems)
- No analgesic or anesthetic medication taken 24 hours before the procedure
- Agree to participate in the study
You will not qualify if you...
- Conversion from topical to general anesthesia during surgery
- Previous eye surgery
- Hearing, speech, physical, or mental disability
- Pregnancy or possible pregnancy
- Malignancy
- Use of analgesic medication within 24 hours before procedure
- Chronic pain
- History of incomplete or canceled cataract procedures
- Hypertension (blood pressure over 160/100 mmHg)
- Infective or inflammatory skin condition on hands
- Hypersensitivity to touch
- Contact-transmitted diseases
- Discomfort with hand holding
- Need for emergency intervention during or after procedure
- Failure to perform stress ball application as instructed
- Pre-existing neuropathy (e.g., muscle, joint problems, stroke)
- Complications during cataract surgery
- Voluntary withdrawal from the study
- Deterioration of general condition leading to procedure termination
- Failure to follow intervention protocol (e.g., dropping stress ball)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (duration of cataract surgery)
Participants receive cataract surgery under topical anesthesia while undergoing one of the interventions: hand holding, stress ball use, or standard care without additional intervention. The interventions are applied starting 1-2 minutes before surgery and continue until the surgery is completed.
1 visit (in-person, surgery day)
Duration - Less than 1 day (15 minutes post-surgery)
Participants are assessed for pain, anxiety, satisfaction, and physiological parameters 15 minutes after the surgery is completed.
1 visit (in-person, post-surgery assessment)
Trial Site Locations
Total: 1 location
1
Yenikent State Hospital
Sakarya, Turkey (Türkiye)
Actively Recruiting
Research Team
A
Aysel GÜL
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here