Stress Ball Use in Patients Undergoing Coronary Angiography

Pain Clinical Trial

Official title:

The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06388681
• Other study ID #: HMKU-KMY-SA-02
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: Mustafa Kemal University
• Contact: SÜMEYYE AKÇOBAN
• Phone: +905434810553
• Email: sumeyyea2016[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography
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 he/she uses 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 hand and left hand until they are mobilized.

Locations

Country	Name	City	State
Turkey	Hatay Mustafa Kemal University	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Genç, H., Korkmaz, M., & Akkurt, A. (2022). The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. Journal of PeriAnesthesia Nursing, 37(3), 344-350. https://doi.org/10.1016/j.jopan.2021.09.006 Gökçe, E., & Arslan, S. (2023). Effects of virtual reality and acupressure interventions on pain, anxiety, vital signs and comfort in catheter extraction processes for patients undergoing coronary angiography: A randomized controlled trial. International Journal of Nursing Practice, 29(6), e13176. https://doi.org/10.1111/IJN.13176 Rejeh, N., Tadrisi, S. D., Yazdani, S., Saatchi, K., & Vaismoradi, M. (2020). The effect of hand reflexology massage on pain and fatigue in patients after coronary angiography: a randomized controlled clinical trial. Nursing research and practice, 2020. Mascarenhas, V. H. A., Lima, T. R., Dantas E Silva, F. M., Dos Santos Negreiros, F., Santos, J. D. M., Moura, M. Á. P., De Oliveira Gouveia, M. T., & Jorge, H. M. F. (2019). Scientific evidence on non-pharmacological methods for relief of labor pain. Acta Paulista de Enfermagem, 32(3), 350-357. https://doi.org/10.1590/1982-0194201900048 Mosaei, M., Dehkordi, A. H., Driees, F., & Salehitali, S. (2020). Audit of the nursing care standards before coronary angiography in patients visiting angiography. Brieflands.Com, 9(3), 1-5. https://doi.org/10.5812/jjcdc.100241 Ozen, N., Berse, S., & Tosun, B. (2023). Effects of using a stress ball on anxiety and depression in patients undergoing hemodialysis: A prospective, balanced, single-blind, crossover study. Hemodialysis International, 27(4), 411-418. https://doi.org/10.1111/HDI.13102

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immobilization Comfort Scale	The Turkish validity and reliability study of the scale developed by Hogan-Miller in 1995 was conducted. The scale consists of 20 items. Each statement in the scale has a Likert-type scoring ranging from 1-6 from "strongly disagree" to "strongly agree". Items 2, 3, 4, 7, 8, 10, 13, 14 and 18 in the scale are negative statements. The total scores obtained from the scale vary between 20 and 120, with a high score indicating good comfort. Cronbach's alpha value of the scale was found to be 0.82.	Comfort assessment with Immobilization Comfort Scale will be performed 2 hours before, 2 hours and 4 hours after sheath extraction.
Primary	Visual Benchmarking Scale	The scale allows patients to measure their own pain level by marking their pain level on a 10 cm ruler at intervals ranging from "no pain" to "most severe pain". The scale has been reported to be more sensitive and reliable than other unidimensional scales in measuring pain level. A study was conducted to standardize this scale and it was found that the vertical use of the scale was better understood by patients. In this model, the patient is told that "the scale has two endpoints and he/she is free to mark any point between these points that corresponds to his/her pain level". The interval between the "pain-free" point and the point marked by the patient is recorded in centimeters using a ruler.	Pain assessment will be performed with Visual Comparison Scale 2 hours before, 2 hours and 4 hours after sheath extraction.
Secondary	Nurse Observation Form	Vital signs (Blood Pressure, Pulse, Temperature, Respiration and Partial Oxygen Pressure) will be taken from the nurse observation form recorded every hour.	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.