- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05174897
The Effect of Emotional Freedom Technique on Fear and Pain in Intravenous Catheter Applications in Pediatric Emergency
The Effect of Emotional Freedom Technique Used in Intravenous Catheter Applications in Pediatric Emergency on Fear and Pain
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yasemin KARAMAN
- Phone Number: 05370586642
- Email: ysmnkrmn95@gmail.com
Study Contact Backup
- Name: Müge SEVAL
- Phone Number: 5053037481
- Email: sevalmuge@gmail.com
Study Locations
-
-
-
Zonguldak, Turkey, 67000
- Recruiting
- Yasemin KARAMAN
-
Contact:
- Müge SEVAL
- Phone Number: 5053037481
- Email: sevalmuge@gmail.com
-
Contact:
- Yasemin KARAMAN
- Phone Number: 5370586642
- Email: ysmnkrmn95@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
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: Experimental group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pen Pain Scale
Time Frame: 0-2 years
|
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
Time Frame: 0-2 years
|
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)
Time Frame: 0-2 years
|
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
Time Frame: 0-2 years
|
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
Time Frame: 0-2 years
|
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
Time Frame: 0-2 years
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/20-9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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