The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs

Sponsor
Aysel Sesci (Other)
Overall Status
Recruiting
CT.gov ID
NCT05867394
Collaborator
(none)
130
1
2
6.5
20

Study Details

Study Description

Brief Summary

It aimed to examine stress, anxiety and resorting to life paths to enable researchers to contain this stress.

Condition or Disease Intervention/Treatment Phase
  • Other: Stress ball
N/A

Detailed Description

Stress and anxiety lives of patients before coronary angiography. The stress and anxiety they experience also affect their vital signs. The researchers aimed to examine the ways the stress ball affected their patients' stress, anxiety, and vital signs.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel Assignment Prospective Randomized Controlled Clinical TrialParallel Assignment Prospective Randomized Controlled Clinical Trial
Masking:
Single (Participant)
Masking Description:
Participants do not know which group they are in.
Primary Purpose:
Prevention
Official Title:
The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs
Actual Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stress ball

Data were collected by the investigator 25-30 minutes before coronary angiography and the first measurement of vital signs was made. After the stress ball application, State Anxiety Inventory data were collected for the second time and the second measurement of vital signs was made. Vital signs were measured and noted for the third time after coronary angiography.

Other: Stress ball
Stress ball squeeze

No Intervention: Control

25-30 minutes before the coronary angiography procedure, data were collected from the patients by the investigator and the first measurements of their vital signs were recorded. Vital signs were measured a second time just before coronary angiography without any intervention. Vital signs were measured and recorded for the third time after coronary angiography ischemia.

Outcome Measures

Primary Outcome Measures

  1. State Anxiety Score [Change in state anxiety score within one day]

    Scale measuring patients' anxiety. The scores obtained from the scale vary between 20 and 80. A large score indicates high anxiety, and a small score indicates low anxiety.

Secondary Outcome Measures

  1. Distress Thermometer [Only on day 1, 2 times a day (same day).]

    It is a scale that measures the patient's stress level. The scale is scored between 0 and 10 points. A score of 0 indicates no stress, and a score of 10 indicates extreme stress.

  2. Systolic Blood Pressure Value (mmHg) [Only on day 1, 2 times a day (same day).]

    The effect of the intervention on systolic blood pressure is examined.

  3. Diastolic Blood Pressure Value (mmHg) [It will be measured 3 times a day (same day) on day 1 only.]

    The effect of the intervention on diastolic blood pressure is examined.

  4. Heart Rate/Minute Value [It will be measured 3 times a day (same day) on day 1 only.]

    The effect of the intervention on the heart rate is examined.

  5. Respiratory Rate/Minute Value [It will be measured 3 times a day (same day) on day 1 only.]

    The effect of the intervention on the respiratory rate is examined.

  6. Peripheral Oxygen Saturation (SpO2) Value [It will be measured 3 times a day (same day) on day 1 only.]

    The effect of the intervention on peripheral oxygen saturation is examined.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 years and over

  • For those who will undergo coronary angiography for the first time

  • Able to read and write

  • Not diagnosed with anxiety disorder and not using medication for it

  • No physical disability to use the stress ball

  • Cognitive health levels consist of individuals who are suitable for answering data collection forms.

Exclusion Criteria:
  • Unconscious and not fully oriented

  • Sight and hearing problems

  • Alzheimer's disease and other types of dementia

  • Having a severe psychiatric problem that cannot answer the questions

  • Those who came with MI (myocardial infarction) and performed CAG

  • Individuals who are closed to communicating are not included in this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aysel SESCİ Aksaray University Turkey 68000

Sponsors and Collaborators

  • Aysel Sesci

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aysel Sesci, principal investigator, Aksaray University
ClinicalTrials.gov Identifier:
NCT05867394
Other Study ID Numbers:
  • Aksaray Üniversitesi
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aysel Sesci, principal investigator, Aksaray University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2023