PainNCT05174897
The Effect of Emotional Freedom Technique on Fear and Pain in Intravenous Catheter Applications in Pediatric Emergency
A study testing emotional liberation technique in people with Pain and Fear, run by Müge SEVAL at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- What is being tested?
- emotional liberation technique
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yasemin KARAMAN
Zonguldak, 67000
Yasemin KARAMAN, 5370586642, ysmnkrmn95@gmail.com
Müge SEVAL, 5053037481, sevalmuge@gmail.com
About this study
Official title: The Effect of Emotional Freedom Technique Used in Intravenous Catheter Applications in Pediatric Emergency on Fear and Pain
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.
Read the 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.
- Being tested
- emotional liberation technique
- Keywords
- Emotional Liberation Technique, intravenous catheter, child emergency
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotional liberation techniqueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: emotional liberation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start1 Nov 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Müge SEVAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Müge SEVAL, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174897
- Sponsor's protocol ID
- 2021/20-9
- Status last verified
- Dec 2021
- First submitted
- 18 Nov 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotional Freedom Technique Used in Intravenous Catheter Applications in Pediatric Emergency on Fear and Pain
- ClinicalTrials.gov ID
- NCT05174897
- Acronym / sponsor ID
- 2021/20-9
- Keywords
- Emotional Liberation Technique, intravenous catheter, child emergency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Müge SEVALUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: emotional liberation techniqueThe 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| emotional liberation techniqueexperimental 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. | Behavioural | Experimental group |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotional liberation technique in people with Pain and Fear, run by Müge SEVAL at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasemin KARAMAN (05370586642, ysmnkrmn95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pen Pain Scale (time frame: 0-2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.