NCT05867394

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

February 28, 2023

Last Update Submit

May 19, 2023

Conditions

Coronary Artery Disease

Keywords

coronary angiographystressanxietyvital signs

Outcome Measures

Primary Outcomes (1)

  • State Anxiety Score

    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.

    Change in state anxiety score within one day

Secondary Outcomes (6)

  • Distress Thermometer

    Only on day 1, 2 times a day (same day).

  • Systolic Blood Pressure Value (mmHg)

    Only on day 1, 2 times a day (same day).

  • Diastolic Blood Pressure Value (mmHg)

    It will be measured 3 times a day (same day) on day 1 only.

  • Heart Rate/Minute Value

    It will be measured 3 times a day (same day) on day 1 only.

  • Respiratory Rate/Minute Value

    It will be measured 3 times a day (same day) on day 1 only.

  • +1 more secondary outcomes

Study Arms (2)

Stress ball

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Stress ballOTHER

Stress ball squeeze

Stress ball

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aysel SESCİ

Aksaray, University, 68000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseAnxiety Disorders

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMental Disorders

Central Study Contacts

Aysel SESCİ

CONTACT

2903aysel.sesci70@icloud.com

Kadriye SAYIN KASAR

CONTACT

2785kadriyekasar@aksaray.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants do not know which group they are in.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel Assignment Prospective Randomized Controlled Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 28, 2023

First Posted

May 22, 2023

Study Start

November 15, 2022

Primary Completion

May 30, 2023

Study Completion

June 1, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Study protocol

Locations

TU(1)