Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04316754
Other study ID # 2019/369
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2020
Est. completion date August 1, 2021

Study information

Verified date December 2021
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research. Before angiography, "Child Fear Scale", "State-Trait Anxiety Scale (STAI-TX)", and "Vital Signs Follow-up Form" will be applied to all children taking part in the study and life signs will be recorded. During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute. "Numerical Pain Scale", "Child Fear Scale", "State Anxiety Scale", and "Vital Signs Follow-up Form" will be re-evaluated to all three groups after angiography.


Description:

This study was planned to determine the effect of music during angiography on pain, fear, anxiety and life signs in children aged 7-18. The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research. Before angiography, "Child Fear Scale", "State-Trait Anxiety Scale (STAI-TX)", and "Vital Signs Follow-up Form" will be applied to all children taking part in the study and life signs will be recorded. The sample size of the study was determined and the effect size was 0.25 based on the Standard effect sizes determined by Cohen. In the study, the sample number of 0.84 in the statistical power α=0.05 confidence interval was calculated as 36 for each group. During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute. "Numerical Pain Scale", "Child Fear Scale", "State Anxiety Scale", and "Vital Signs Follow-up Form" will be re-evaluated to all three groups after angiography.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date August 1, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers No
Gender All
Age group 7 Years to 18 Years
Eligibility Inclusion Criteria: - Volunteering to participate in research - Being between 7-18 years of age - Lack of communication problems (vision, hearing, mental) - Being informed about surgical intervention - Lack of prior surgical intervention experience - Receiving sedoanalgesia during angiography Exclusion Criteria: - Intubation of the child during angiography - Parent's refusal to take part in the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
music
During angiography, the Intervention-1 group will listen to the music that the child wants to listen to. The Intervention-2 group will listen to the "Arts of Fugue" by Bach. No music will be played to the control group.

Locations

Country Name City State
Turkey Dr. Behcet Uz Children's Hospital Izmir

Sponsors (2)

Lead Sponsor Collaborator
Izmir Katip Celebi University Dr. Behcet Uz Children's Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary child's heart rate the child's pulse rate will be measured. baseline (at the beginning of angiography)
Primary child's heart rate the child's pulse rate will be measured. 1st minute of the angiography
Primary child's heart rate the child's pulse rate will be measured. 5th minute of the angiography
Primary child's heart rate the child's pulse rate will be measured. 10th minute of the angiography
Primary child's heart rate the child's pulse rate will be measured. 30th minute of the angiography
Primary child's heart rate the child's pulse rate will be measured. 60th minute of the angiography
Primary child's respiratory rate the child's respiratory rate will be measured. Baseline (at the beginning of angiography)
Primary child's respiratory rate the child's respiratory rate will be measured. 1st minute of the angiography
Primary child's respiratory rate the child's respiratory rate will be measured. 5th minute of the angiography
Primary child's respiratory rate the child's respiratory rate will be measured. 10th minute of the angiography
Primary child's respiratory rate the child's respiratory rate will be measured. 15th minute of the angiography
Primary child's respiratory rate the child's respiratory rate will be measured. 30th minute of the angiography
Primary child's respiratory rate the child's respiratory rate will be measured. 60th minute of the angiography
Primary child's blood pressure the child's blood pressure will be measured. baseline (at the beginning of angiography)
Primary child's blood pressure the child's blood pressure will be measured. 1st minute of the angiography
Primary child's blood pressure the child's blood pressure will be measured. 5th minute of the angiography
Primary child's blood pressure the child's blood pressure will be measured. 10th minute of the angiography
Primary child's blood pressure the child's blood pressure will be measured. 15th minute of the angiography
Primary child's blood pressure the child's blood pressure will be measured. 30th minute of the angiography
Primary child's blood pressure the child's blood pressure will be measured. 60th minute of the angiography
Primary child's body temperature the child's body temperature will be measured. Baseline (at the beginning of angiography)
Primary child's body temperature the child's body temperature will be measured. 1st minute of the angiography
Primary child's body temperature the child's body temperature will be measured. 5th minute of the angiography
Primary child's body temperature the child's body temperature will be measured. 10th minute of the angiography
Primary child's body temperature the child's body temperature will be measured. 15th minute of the angiography
Primary child's body temperature the child's body temperature will be measured. 30th minute of the angiography
Primary child's body temperature the child's body temperature will be measured. 60th minute of the angiography
Primary child's oxygen saturation the child's oxygen saturation will be measured. baseline (at the beginning of angiography)
Primary child's oxygen saturation the child's oxygen saturation will be measured. 1st minute of the angiography
Primary child's oxygen saturation the child's oxygen saturation will be measured. 5th minute of the angiography
Primary child's oxygen saturation the child's oxygen saturation will be measured. 10th minute of the angiography
Primary child's oxygen saturation the child's oxygen saturation will be measured. 15th minute of the angiography
Primary child's oxygen saturation the child's oxygen saturation will be measured. 30th minute of the angiography
Primary child's oxygen saturation the child's oxygen saturation will be measured. 60th minute of the angiography
Primary child's fear Child fear will be assessed by "Children's Fear Scale". This scale includes 5 different facial expressions. This scale is rated from 0-4 and it is stated that it is a reliable and valid measurement tool for the assessment of fear. up to 60 min (when the child wakes up from anaesthetic)
Primary child's anxiety Child anxiety will be assessed by the "State Anxiety Scale". This scale includes 5 different facial expressions. The children are expected to evaluate how they feel at the moment. Expressions such as "I feel very angry", "I feel angry or" I do not feel angry "are asked to mark the most appropriate one for them.
The total number of items is 20. The lowest score is 20, the highest the score is 60.
up to 60 min (when the child wakes up from anaesthetic)
Primary child's pain Child pain will be assessed by the " Numeric Pain Scale". This method is intended to determine the severity of pain and to explain the patient's pain in numbers. On numerical scales, it starts with the absence of pain (0) and reaches the level of unbearable pain (10). up to 60 min (when the child wakes up from anaesthetic)
See also
  Status Clinical Trial Phase
Recruiting NCT03369886 - The Relationship Between Macular OCTA and GCIPL and Their Combinational Index Using AI N/A
Completed NCT02837744 - Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure
Completed NCT03762525 - Iliac Branch Device Movement During Cardiac Cycle (IBD-dynamics) N/A
Completed NCT05588232 - the Effectiveness of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures N/A
Recruiting NCT03574636 - OCT vs IVUS vs QCA to Guide Moderate-to-severe Calcified Lesion Stent Implantation N/A
Recruiting NCT04876222 - Direct or Subacute Coronary Angiography in Patients With Out of Hospital Cardiac Arrest Without Coma. N/A
Completed NCT01100476 - Mynx M5 One Hour Ambulation Study Phase 4
Completed NCT03645902 - Comparison Between TOF and SWAN Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI
Recruiting NCT05417022 - Safety and Efficacy Evaluation of Orbital Atherectomy System in de Novo Calcified Lesions
Completed NCT02840903 - A Non-interventional Study to Observe the Computed Tomographic Angiography Image Quality With Different Contrast Media Injection Protocols Under Different Computed Tomography Machines Parameters Setting
Recruiting NCT03778645 - Adrenal Venous Sampling Via an Antecubital Approach
Completed NCT03821753 - The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes
Terminated NCT00732628 - Evaluating Outcomes in the Placement of Boomerang Percutaneous Device N/A
Terminated NCT03060460 - Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty N/A
Not yet recruiting NCT05511675 - The Effect of Cold Application on the Hemostasis, Extremity Pain And Terumo Band Usage After Transradial Angiography N/A