NCT06844682

Brief Summary

After coronary angiography, back pain and comfort levels were measured while the intervention group was positioned and the control group was not positioned

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
Last Updated

February 25, 2025

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 14, 2024

Last Update Submit

February 19, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • control group

    Patients were put to bed in the supine position at the exit of the CAG in accordance with the routine practice of the clinic and were allowed to stay in this position for 6 hours. When the patient was put to bed, VAS was applied for the patient introduction form, comfort and pain (0. hour). 2 From the withdrawal of mattresses. and 4. during the hours, VAS was applied. The patients' back pain and comfort were evaluated and the results were recorded in the relevant forms.

    three months

  • intervention group

    The patients were put to bed after KAG. The first measurement was taken when he was put to bed after KAG. The patient introduction form, VAS were applied for comfort and pain (0. At sa Tu). Following the withdrawal of the mattresses, the patient was given the semi-fawler position. 2 After being given the position. and 4. hours later, VAS was applied. The back pain and comfort of the patients were evaluated with the given position and the results were recorded on the relevant forms.

    three months

Study Arms (2)

control group

NO INTERVENTION

At the end of CAG, the patients were laid in the supine position in line with the routine practice of the clinic and were allowed to remain in this position for 6 hours. While lying in bed, the patient identification form and VAS for comfort and pain were applied (Hour 0). VAS was applied at the 2nd and 4th hours following the removal of the mattresses. The patients' back pain and comfort were evaluated and the results were recorded on the relevant forms.

intervention group

EXPERIMENTAL

After CAG, the patients were placed on the bed in the supine position. The first measurement was taken when he was put to bed after CAG, and the patient introduction form and VAS for comfort and pain were applied (0th hour). Following the removal of the mattresses, the patient was placed in the semi-fawler position. VAS was applied 2 and 4 hours after positioning. The patients' back pain and comfort were evaluated with the given position, and the results were recorded on the relevant forms.

Other: intervention group

Interventions

Following the removal of the mattresses, the patient was placed in the semi-fawler position.

intervention group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary angiography for the first time in the coronary intensive care unit and cardiology clinic
  • Volunteer to participate in the study
  • Femoral angiography procedure performed
  • It created patients who had no obstacle to communication.

You may not qualify if:

  • More than one coronary angiography procedure was performed
  • Not volunteering to participate in the study
  • Radial angiography procedure was performed
  • Having a history of back surgery, existing hernia, or chronic waist or back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eyüp

Gaziantep, şahinbey, 27000, Turkey (Türkiye)

Location

Study Officials

  • Eyüp FIRAT

    SANKO Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Patients were assigned to the control and intervention groups by the minimization method. (Minimization was carried out according to parameters such as age, gender, and body mass index (BMI). A computer program that generates random numbers was used for the randomization process. In accordance with the randomization list, patients were randomly divided into intervention group and control group according to the order of admission to the hospital.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

November 14, 2024

First Posted

February 25, 2025

Study Start

November 5, 2023

Primary Completion

January 10, 2024

Study Completion

February 28, 2024

Last Updated

February 25, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations