NCT05174897

Brief Summary

This study was planned to determine the effect of emotional liberation technique (EFT) in reducing fear and pain in intravenous catheter applications in children aged 10-14 years admitted to the pediatric emergency department.

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
70

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable pain

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

November 18, 2021

Last Update Submit

December 13, 2021

Conditions

Keywords

Emotional Liberation Techniqueintravenous catheterchild emergency

Outcome Measures

Primary Outcomes (6)

  • Pen Pain Scale

    It will be used to measure the pain scores of children in the experimental and control groups before, during and after the procedure. The pencil used as a scale is a handmade pencil whose raw material is wood and measures 17 cm in length, 5 cm in circumference and 1.59 cm in diameter. In the middle of the pen, a monthly 5 cm long, parallel to its neck, is formed and drawn in orange around it to be decisive. A 5 cm measurement line was drawn by hand in the middle of the recess and is numbered from 0 to 5. While the value near the tip of the pen indicates 0 and the value near the base indicates 5, the value 0 means no pain and 5 means unbearable pain.

    0-2 years

  • Medical Procedures Fear Scale

    Medical Procedures Fear Scale It will be used to calculate the fear scores of the children in the experimental and control groups before, during and after the procedure. The scale items were prepared in the form of a structured Likert-type 3-point timed option, and the child was required to choose one of the statements 'I am not afraid at all', 'I am somewhat afraid', 'I am very afraid' for each item. Scores range from 29 to 87, and those with low scores constitute the group that is least afraid of medical procedures.

    0-2 years

  • Subjective Experience Scale(SUE)

    As the subjective scoring of the experience, it will be applied to the children in the experimental group before and after the procedure. An SUE assessment is done before the EFT round begins. After the EFT round is complete, the SUE scale is repeated to see how much the situation has changed. on a scale from -10 to +10; -10 indicates the greatest imaginable level of pain, frustration, fear, stress, sadness, or discomfort. +10; It includes the highest levels of joy, happiness, or feeling great.

    0-2 years

  • Heart rate

    The heart rate of the children was recorded by measuring with a pulse oximeter placed on the right or left finger of each child. Heart rate was recorded before, during and after the procedure.

    0-2 years

  • oxygen saturation

    The oxygen saturation value of the children was measured with a pulse oximeter placed on the right or left finger of each child and recorded. Oxygen value was recorded before, during and after the procedure.

    0-2 years

  • respiratory rate

    The respiratory rate of the children was evaluated by the researcher within one minute. Respiratory values were recorded before, during and after the procedure.

    0-2 years

Study Arms (2)

Control Group

NO INTERVENTION

The child for whom an intravenous catheter will be applied will be placed on a stretcher and pain and fear will be evaluated before the procedure. Afterwards, an intravenous catheter will be applied. Pain and fear scores will be evaluated during and after the procedure.

Experimental group

EXPERIMENTAL

The child to whom an intravenous catheter will be applied is placed on a stretcher. After evaluating the pain and fear score before the procedure, emotional liberation technique (EFT) is performed for 10 minutes. followed by an intravenous catheter. Pain and fear scores are evaluated during and after the procedure.

Behavioral: emotional liberation technique

Interventions

experimental group; The child, to whom an intravenous catheter will be applied, is placed on a stretcher. pain ve score fear will be evaluated before the procedure. Then, the emotional liberation technique (EFT) will be applied for 10 minutes and an intravenous catheter will be applied to evaluate the pain and fear scores during and after the procedure.

Experimental group

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Be between the ages of 10-14
  • The child is awake/cooperative
  • No life-threatening condition/No medical contraindications
  • Absence of physical/mental/cognitive development problems Having one of the diagnoses of fever, bronchitis/asthma, nausea-vomiting, abdominal pain, allergy
  • The child's willingness and declaring it in writing
  • Children of families who signed the informed consent form by accepting to participate in the study will be included in the study.

You may not qualify if:

  • not be between the ages of 10-14
  • The child is not alert/cooperative
  • There is a life-threatening condition/There is a medical contraindication
  • Having a physical/mental/cognitive development problem Not having one of the diagnoses of fever, bronchitis/asthma, nausea-vomiting, abdominal pain, allergy
  • The child does not want to participate in the study
  • families' refusal to work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasemin KARAMAN

Zonguldak, 67000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Yasemin KARAMAN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The aim of this study is to evaluate the effect of emotional liberation technique (EFT) in reducing fear and pain during intravenous catheterization in children aged 10-14 years who applied to the emergency department.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The research was planned as a randomized controlled study to examine the effect of the emotional freedom technique used in intravenous catheter applications in the pediatric emergency on fear and pain in children aged 10-14 years. The entire sample was numbered from 1 to 70, and odd numbers were assigned to the control group and even numbers to the intervention group. Randomization was performed by an independent nurse other than the researcher.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctoral Lecturer

Study Record Dates

First Submitted

November 18, 2021

First Posted

January 3, 2022

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

March 30, 2023

Last Updated

January 3, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations