Stress Ball Use During Cataract Surgery: Effects on Pain, Fear and Satisfaction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBezmialem Vakif University
About this trial
The aim of this study is to determine the effect of stress ball use during cataract surgery on patients' pain, fear, and satisfaction levels.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 18 years or older,
Without hearing or cognitive impairments,
Without any neurological conditions that would prevent squeezing a stress ball,
Without any physical limitations in the hands or arms that would prevent squeezing a stress ball,
Disqualifiers
Under 18 years of age,
Change in anesthesia type during surgery (from topical anesthesia to general anesthesia)
Patients scheduled for cataract surgery under general anesthesia,
Patients with psychiatric disorders,
Trial design
Design model
Parallel
Treatments tested in this trial
Use of a stress ball during cataract surgery
Other interventionTo examine the effect of using a stress ball, a non-pharmacological method, during scheduled cataract surgery on patients' pain, surgical fear, and satisfaction levels.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Experimental group: the group using a stress ballExperimental treatment 1 intervention
Group B: Control group: Patients who did not use a stress ballNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Patient Information Form
Prepared by researchers based on a review of similar studies on the subject in the literature. The form contains six (6) questions regarding the socio-demographic characteristics of patients who have undergone cataract surgery, including age, marital status, educational status, employment status, and economic status; and six (6) questions regarding the presence of chronic diseases, regular medication use, smoking/alcohol consumption, previous hospitalizations, and previous cataract surgeries, for a total of 12 questions.
Time frame
Time point 1: preoperatively (immediately before surgery)2
Visual Analogue Scale (VAS)
First defined in 1921 and used to assess patients' subjective pain levels, the VAS is a form consisting of a horizontal line 10 cm long. The leftmost part of this measurement tool indicates "no pain," while the rightmost part indicates "unbearable pain." A high score on the scale indicates severe pain, while a low score indicates mild pain. The scale is scored as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.
Time frame
Time point 1: preoperatively (immediately before surgery) Time point 2: intraoperatively Time point 3: immediately postoperatively3
Surgical Fear Questionnaire (SFQ)
Developed by Theunissen et al. (2014), this scale consists of 8 items and aims to assess the long- and short-term levels of anxiety experienced by patients scheduled for elective surgery. The Turkish validity and reliability study was conducted by Bağdigen and Karaman Özlü in 2016. The scale consists of 11 Likert-type items, a total of eight items, and two subscales: fear of the short-term and long-term outcomes of surgery. Items 1 to 4 inquire about the short-term outcomes of surgery, while items 5 to 8 inquire about the long-term outcomes.The Cronbach's alpha coefficient for the CKÖ total score was found to be 0.934, for the CKÖ-Short-term fears subscale 0.960, and for the CKÖ-Long-term fears subscale 0.907. As the scale score increases, the patients' level of surgical fear increases.
Time frame
Time point 1: preoperatively (immediately before surgery) Time point 2: intraoperatively Time point 3: immediately postoperatively4
Visual Comparison Scale for Satisfaction
In this scale, satisfaction levels are determined by scoring between 0 and 10. A score of "0" represents the lowest level of satisfaction, while a score of "10" represents the highest level of satisfaction. Patients are asked to indicate the level of their pain on a scale from 0 to 10, with the numerical value representing the patient's satisfaction level.
Time frame
Time point 1: intraoperatively Time point 2: immediately postoperativelySponsors and contacts
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Source ClinicalTrials.gov