Stress Ball Use in Patients Undergoing Coronary Angiography

NCT06388681 | Completed

• 1 other identifier: HMKU-KMY-SA-02
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Vital Signs; Patient Comfort; Angiography

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Nurse Observation Form

  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.

Study Arms (2)

Experimental

EXPERIMENTAL

Intervention Group Patients in the intervention group will be allowed to use a stress ball. The comfort level, vital signs and pain intensity of the patients in the intervention group will be evaluated with the Immolization comfort scale 2 hours before Sheath extraction. Pain intensity and vital signs will be evaluated 2 hours after sheath extraction, and comfort level, vital signs and pain intensity will be evaluated with Immolization comfort scale 4 hours after sheath extraction. Stress Ball Use Practice for the Intervention Group 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 and left hand until they are mobilized.

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

Control Group

NO INTERVENTION

Control Group 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.

Interventions

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

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 35397973 BACKGROUND

• 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.

  PMID: 32908698 BACKGROUND

• Akcoban S, Tosun B, Yuksel H. The Effect of Stress Ball Use on Immobilization Comfort, Pain Level, and Vital Signs in Patients After Coronary Angiography. J Cardiovasc Nurs. 2026 Jan-Feb 01;41(1):E25-E32. doi: 10.1097/JCN.0000000000001202. Epub 2025 Apr 9.

  PMID: 40198758 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Vital Signs

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• SÜMEYYE AKÇOBAN

  Mustafa Kemal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: April 24, 2024
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)