Clinical trial NCT06388681: Stress Ball Use in Patients Undergoing Coronary Angiography
Official title: The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Vital Signs
Patient Comfort
Angiography
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: One of the nonpharmacologic interventions included in the NIC-Nursing Interventions Classification is the use of stress balls. Stress balls are one of the cognitive distraction methods used especially in reducing pain and increasing the comfort level of patients. On the other hand, there are studies showing that stress balls have a positive effect not only on pain but also on vital signs, anxiety and comfort level of the patient.

Detailed description: The study will be conducted in the cardiology clinics of a state hospital between April 2024 and June 2024. The study was planned as a randomized experimental study to examine the effect of stress ball use on immobilization comfort, pain level and vital signs in patients undergoing coronary angiography. The population of the study consisted of patients admitted to the cardiology clinic of a state hospital. G\*Power 3.1.9.7 program was used for sample size calculation. Cohen's standardized effect size was used since no study with similar sample characteristics and criteria was found. Friedman's F Test was used to evaluate whether the effect on immobilization comfort, pain level and vital signs differed between the intervention and control groups of patients undergoing angiography through the femoral artery. Accordingly, the sample size was determined as (n=66), intervention group (n=33), control group (n=33) with a low effect size (0.2) in line with the relevant tests and a pyori calculation with α error=0.05, (1-β error) =0.95. A total of 72 patients, 36 in each group, were planned to be included in the study with a 10% patient loss. The patient information form prepared by the investigators will be filled in before transfer to the angiography procedure room for the patients who were determined as intervention (n=36) and control group (n=36). Data will be evaluated in 3 stages: 2 hours before sheath extraction, 2 hours after sheath extraction and 4 hours after sheath extraction. The researchers will explain and demonstrate to the intervention group how to use the stress ball. Then, the patient will be asked to use the ball and it will be confirmed whether they use it correctly. After angiography, it will be stated that the patients in the intervention group should count to 5 and squeeze it once for 10 minutes every hour and rotate with the right and left hand until they are mobilized. The stress ball used will be of medium hardness and made of high quality silicone. Stress balls will be provided by the researchers and given to the patients. Patients in the control group will not undergo any intervention. Comfort level, vital signs and pain will be evaluated with Immolization comfort scale 2 hours before Sheath extraction. Pain and vital signs will be evaluated 2 hours after Sheath extraction and comfort level, vital signs and pain will be evaluated with Immolization comfort scale 4 hours after Sheath extraction.

Eligibility criteria: Inclusion Criteria:

* Who are over 18 years old,
* Having no barriers to written and verbal communication in Turkish,
* Patients without chronic dermatological and/or vascular disease
* Patients undergoing angiography via the femoral artery will be included in the trial

Exclusion Criteria:

* Patients who cannot communicate verbally
* Patients with a psychiatric diagnosis
* Patients who drop out of the study at any stage of the study
* Patients who underwent angiography using an artery other than the femoral artery will not be included in the study.

Primary outcomes:
measure: Immobilization Comfort Scale
timeFrame: Comfort assessment with Immobilization Comfort Scale will be performed 2 hours before, 2 hours and 4 hours after sheath extraction.
measure: Visual Benchmarking Scale
timeFrame: Pain assessment will be performed with Visual Comparison Scale 2 hours before, 2 hours and 4 hours after sheath extraction.
Secondary outcomes:
measure: Nurse Observation Form
timeFrame: 2 hours before the sheath extraction, 2 hours and 4 hours after the sheath extraction; vital signs will be evaluated with the vital signs recorded on the Nurse Observation Form.
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University
Study officials:
affiliation: Mustafa Kemal University
name: SÜMEYYE AKÇOBAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
citation: Rejeh N, Tadrisi SD, Yazdani S, Saatchi K, Vaismoradi M. The Effect of Hand Reflexology Massage on Pain and Fatigue in Patients after Coronary Angiography: A Randomized Controlled Clinical Trial. Nurs Res Pract. 2020 Aug 29;2020:8386167. doi: 10.1155/2020/8386167. eCollection 2020.