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The Effect of Emotional Freedom Technique on Fear and Pain in Intravenous Catheter Applications in Pediatric Emergency

Primary Purpose

Pain, Fear

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
emotional liberation technique
Sponsored by
Müge SEVAL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring Emotional Liberation Technique, intravenous catheter, child emergency

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Yasemin KARAMANRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Experimental group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2021
Last Updated
December 13, 2021
Sponsor
Müge SEVAL
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1. Study Identification

Unique Protocol Identification Number
NCT05174897
Brief Title
The Effect of Emotional Freedom Technique on Fear and Pain in Intravenous Catheter Applications in Pediatric Emergency
Official Title
The Effect of Emotional Freedom Technique Used in Intravenous Catheter Applications in Pediatric Emergency on Fear and Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Müge SEVAL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Emotional Freedom Technique is an easy-to-apply therapy method, which is one of the energy psychotherapy methods. The basic principle of the technique is that every limiting thought, disturbing emotion and memory that the individual has is related to the disruption of the electrical flow in his body and creating congestion. When children apply to the hospital due to illness, they feel anxiety, fear and are exposed to unpleasant procedures that disturb them. Illness and hospitalization cause trauma for children of all age groups. However, there are negative effects on the development of children. Experiencing negative physical events, undergoing surgery and separation of children from their families is a difficult process for them. Children who experience negative emotions during this difficult process also worry about physical limitations. In this case, unlike other friends, they may feel inadequate and blocked. Children experience more uncertain feelings about all procedures to be performed in the hospital than adults. The fact that children have to be in the hospital causes them to experience physiological, emotional and behavioral problems. In these cases, it is important to reduce the negative effects of hospital admissions on children. Pediatric pain itself is a problem for a child, their parents, and medical staff in a pediatric emergency room. Studies have shown that up to 80% of emergency room patients undergo painful diagnostic procedures such as vein puncture, intravenous insertion and removal, tape removal, and urine sampling. Painful procedures are often unexpected. It therefore intensifies the stress and anxiety associated with the hospital, leading to unpleasant experiences and bad memories associated with medical settings that can adversely affect procedure results. It can also affect future visits and increase the patient's fears. The simple thought of visiting hospital settings can also be distressing for a child. A crowded emergency room environment can be a source of fear and anxiety for children. Children's age and gender, development and communication level, different personalities and temperaments, individual clinical situation and personal response to a painful stimulus should also be addressed. However, studies in the literature on reducing the anxiety and fears of children in the pediatric emergency service were also found to be insufficient. It is the pain that children are most exposed to in hospitals and during the interventional procedures they do not want. According to the definition of the International Pain Research Organization, pain is; They are unpleasant, sensory and emotional states that are affected by the past experiences of individuals resulting from actual or potential tissue damege. Each child perceives and expresses pain differently. Pain control in children begins with the assessment of pain. Afterwards; Relief of the child's pain and the ability to cope with pain increase the quality of life is provided. Although it is preferred because we all know about the control of pain and the effect of pharmacological methods is seen quickly with its easy applicability, excessive and unconscious use affects physiological functions negatively. Today, although its use has increased compared to the past, non-pharmacological methods that have not reached a sufficient level can be applied easily without harming the body. It can also be applied in pain management by increasing the release of endorphins, the body's natural morphine. There are many non-pharmacological methods that can be applied to us. One of them is acupressure applications. With the acupressure application, gentle strokes are made on the acupuncture points in the body. With these touches, the nociception process begins and the impulses stimulate the serotoninergic and enkephalinergic agents to activate the analgesic system. An EFT tour is carried out by making light strokes on the transit points of the 14 main meridians in the body. The basic application of EFT is respectively; It starts with the determination of the subjective discomfort level Subjective Units of Disturbance/ SUD. Here on a scale from -10 to +10; -10 of the greatest pain, fear, stress and sadness imaginable; +10 allows us to evaluate the scaling that includes the highest levels of joy, happiness, and well-being. Next, the preparation or setup sentence is formed and repeated by rubbing the space between the chest and shoulder. The sentences are repeated and the acupuncture points are hit in order. After the EFT tour, it is evaluated whether there is a difference in the level of discomfort of the individual with the SUD scale. When measured against the standards of the American Psychological Association's Chapter 12 Task Force on Empirically Validated Therapies, EFT has been found to be an evidence-based practice for anxiety, depression, phobias, and post-traumatic stress disorder. When the literature studies are examined; Positive results of EFT were obtained and no side effects were observed. Emotional liberation techniques are used in children with test anxiety, fear, bedwetting, nightmares, sleep disorders, stress, school problems, learning difficulties and problems related to self-esteem. A study was conducted on the severity of venipuncture pain in hospitalized children aged 6-12 in Iran, comparing acupressure and topical anesthesia applications to Yintang and Laogong points. As a result of the study, it was seen that acupressure was as effective as topical anesthetic cream in relieving venipuncture pain in children. At the same time, the study suggests the use of acupressure practice in nurses' pediatric clinical. In another study example; Acupressure was applied 10 minutes before the venipuncture application and it was found to be effective in reducing the pain experienced by children. In another study example, the effect of acupressure on pain after tonsillectomy in adolescents. evaluated. In a study conducted with 144 children aged 5-12 years, it was observed that acupressure had a positive effect on reducing pain after tonsillectomy surgery. It has also proven to be a noninvasive, safe and effective method. The use of studies in clinics is recommended and their dissemination should be ensured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Fear
Keywords
Emotional Liberation Technique, intravenous catheter, child emergency

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
emotional liberation technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pen Pain Scale
Description
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.
Time Frame
0-2 years
Title
Medical Procedures Fear Scale
Description
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.
Time Frame
0-2 years
Title
Subjective Experience Scale(SUE)
Description
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.
Time Frame
0-2 years
Title
Heart rate
Description
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.
Time Frame
0-2 years
Title
oxygen saturation
Description
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.
Time Frame
0-2 years
Title
respiratory rate
Description
The respiratory rate of the children was evaluated by the researcher within one minute. Respiratory values were recorded before, during and after the procedure.
Time Frame
0-2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasemin KARAMAN
Phone
05370586642
Email
ysmnkrmn95@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Müge SEVAL
Phone
5053037481
Email
sevalmuge@gmail.com
Facility Information:
Facility Name
Yasemin KARAMAN
City
Zonguldak
ZIP/Postal Code
67000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasemin KARAMAN
Phone
5370586642
Email
ysmnkrmn95@gmail.com
First Name & Middle Initial & Last Name & Degree
Müge SEVAL
Phone
5053037481
Email
sevalmuge@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Emotional Freedom Technique on Fear and Pain in Intravenous Catheter Applications in Pediatric Emergency

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