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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05174897
Other study ID # 2021/20-9
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date March 30, 2023

Study information

Verified date December 2021
Source Zonguldak Bulent Ecevit University
Contact Yasemin KARAMAN
Phone 05370586642
Email ysmnkrmn95@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date March 30, 2023
Est. primary completion date November 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
emotional liberation technique
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.

Locations

Country Name City State
Turkey Yasemin KARAMAN Zonguldak

Sponsors (1)

Lead Sponsor Collaborator
Müge SEVAL

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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