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The Effect of "Quantum Touch" Application on Transfer Anxiety in Pediatric Patients and Their Parents Planned to be Hospitalized in the Emergency Department

Primary Purpose

Anxiety, Child, Only, Emergencies

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Quantum Touch
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being between 5-10 years old (the fear scale used for children can be used for 5-10 years old)
  • Planning hospitalization from the emergency department to the clinic
  • Absence of any mental and/or physical health problems that would prevent communication
  • Parents and children speak Turkish
  • Parent and child volunteer to participate in the study.

Exclusion Criteria:

Being under 5 years old and over 10 years old

  • Having any mental and/or physical health problems that prevent communication
  • Parents and children do not agree to participate in the study.

Sites / Locations

  • Istanbul Zeynep Kamil Gynecology and Pediatrics Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Quantum Touch

Control

Arm Description

Those who are planned to be hospitalized from the emergency department and applied quantum touch

Those who are planned to be hospitalized from the emergency department and who have not intervention

Outcomes

Primary Outcome Measures

Child Fear Scale
The CFS is a scale from 0 to 4, consisting of five drawn facial expressions ranging from neutral (0=no anxiety) to frightened face (4=severe anxiety).
Child Anxiety Scale-State
CAS-S is similar to a thermometer with a light bulb at the bottom and horizontal lines at intervals that go up. The scale is aimed at children between the ages of four and ten. To measure state anxiety (CAS-S), the child is asked to mark what he feels "right now".

Secondary Outcome Measures

Full Information

First Posted
May 13, 2022
Last Updated
August 22, 2023
Sponsor
Istanbul Medeniyet University
Collaborators
Health Science University Zeynep Kamil Women and Children's Disease Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05380466
Brief Title
The Effect of "Quantum Touch" Application on Transfer Anxiety in Pediatric Patients and Their Parents Planned to be Hospitalized in the Emergency Department
Official Title
The Effect of "Quantum Touch" Application on Transfer Anxiety in Pediatric Patients and Their Parents Planned to be Hospitalized in the Emergency Department
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
Collaborators
Health Science University Zeynep Kamil Women and Children's Disease Training and Research Hospital

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
Anxiety, which is a subjective experience in which many emotions such as worry, uncertainty, restlessness, and sadness are experienced together, is defined as "a state of tension that arises as a result of the internal conflict experienced by the individual". Emergency services are the units where all kinds of patients and injured are followed and treated 24 hours a day, and anxiety is a very common emotional reaction in patients who apply to the emergency department and their relatives. The patient and his family; They experience varying levels of anxiety due to a sudden and unexpected deterioration of health, the threat of their life, the uncertainty of the situation, the fear of death, role changes, disruption of routines, and being in an unfamiliar hospital environment. With the increase of anxiety, distraction in family members, repetitive questions to health personnel, inability to understand the importance of the event and difficulty in making decisions can be seen.Leaving the emergency room as well as being in the emergency room causes anxiety in individuals. The anxiety experienced in this situation is called transfer anxiety. Transfer anxiety is often defined as "anxiety experienced by an individual when he/she moves from a safe and familiar environment to an unfamiliar environment" and was accepted as a nursing diagnosis by NANDA in 1992. Transferring the patient from the emergency room to the clinic is a routine procedure for emergency nurses, but it causes anxiety for the patient and their relatives. As a result of transfer anxiety, many patients and their family members experience widespread confusion both before and after transfer and tend to certain problems. The patient and family members experience anxiety when they are in a foreign environment with different routines and follow-up procedures for the first time and do not know what to expect. Pharmacological and non-pharmacological methods are used to reduce anxiety. Cognitive behavioral therapy techniques are frequently used among non-pharmacological methods. Cognitive-behavioral therapies are a form of treatment developed on the basis of behavioral psychological counseling theory, which is problem-focused, deals with the "here and now" and applies learning theories to help individuals when they encounter difficulties and life problems that they cannot overcome in their daily lives. Cognitive-behavioral therapies that are highly suitable for working with children, youth, adults, the elderly and families; They are easy to work with individually or in groups and do not require any hardware. Among cognitive behavioral therapy techniques, therapy strategies that reduce anxiety include relaxation, biofeedback, systematic desensitization, exercise, vestibular desensitization, response prevention, and therapeutic touch techniques. Therapeutic touch; In 1972, it was started to be used as a healing method by the manipulation of hypothetical human bioenergy field by nurse professor Doores Krieger. In the literature, it is frequently applied to reduce pain and anxiety in nursing studies and successful results are obtained. Quantum-Touch; It is one of the therapeutic touch techniques and is a biofield therapy that uses life force energy to facilitate healing. Quantum-Touch was first described by Richard Gordon and Bob Rasmusson in 1978; It activates life force energy by combining various hand positions, various breathing techniques and body awareness exercises. It is applied by directing the formed high energy field to an area of pain, stress or illness through therapeutic touch. Tully (2017) found that Quantum Touch in reducing acute and chronic pain; Walton (2011) reported that Quantum-Touch application is effective in chronic musculoskeletal pain. The patient and/or the patient's family may be physically ready for relocation in the hospital environment, but they are not psychologically ready. Inadequate preparation of the individual for the transfer from the emergency room to the clinic or lack of information about the transfer, perceiving that his safety is under threat, and experiencing uncertainty about his situation cause transfer anxiety. Although it is seen in the literature that transfer anxiety is applied in adults and generally in intensive care units, no study has been found in children and emergency services.
Detailed Description
Anxiety, which is a subjective experience in which many emotions such as worry, uncertainty, restlessness, and sadness are experienced together, is defined as "a state of tension that arises as a result of the internal conflict experienced by the individual". Emergency services are the units where all kinds of patients and injured are followed and treated 24 hours a day, and anxiety is a very common emotional reaction in patients who apply to the emergency department and their relatives. The patient and his family; They experience varying levels of anxiety due to a sudden and unexpected deterioration of health, the threat of their life, the uncertainty of the situation, the fear of death, role changes, disruption of routines, and being in an unfamiliar hospital environment. With the increase of anxiety, distraction in family members, repetitive questions to health personnel, inability to understand the importance of the event and difficulty in making decisions can be seen.Leaving the emergency room as well as being in the emergency room causes anxiety in individuals. The anxiety experienced in this situation is called transfer anxiety. Transfer anxiety is often defined as "anxiety experienced by an individual when he/she moves from a safe and familiar environment to an unfamiliar environment" and was accepted as a nursing diagnosis by NANDA in 1992. Transferring the patient from the emergency room to the clinic is a routine procedure for emergency nurses, but it causes anxiety for the patient and their relatives. As a result of transfer anxiety, many patients and their family members experience widespread confusion both before and after transfer and tend to certain problems. The patient and family members experience anxiety when they are in a foreign environment with different routines and follow-up procedures for the first time and do not know what to expect. Pharmacological and non-pharmacological methods are used to reduce anxiety. Cognitive behavioral therapy techniques are frequently used among non-pharmacological methods. Cognitive-behavioral therapies are a form of treatment developed on the basis of behavioral psychological counseling theory, which is problem-focused, deals with the "here and now" and applies learning theories to help individuals when they encounter difficulties and life problems that they cannot overcome in their daily lives. Cognitive-behavioral therapies that are highly suitable for working with children, youth, adults, the elderly and families; They are easy to work with individually or in groups and do not require any hardware. Among cognitive behavioral therapy techniques, therapy strategies that reduce anxiety include relaxation, biofeedback, systematic desensitization, exercise, vestibular desensitization, response prevention, and therapeutic touch techniques. Therapeutic touch; In 1972, it was started to be used as a healing method by the manipulation of hypothetical human bioenergy field by nurse professor Doores Krieger. In the literature, it is frequently applied to reduce pain and anxiety in nursing studies and successful results are obtained. Quantum-Touch; It is one of the therapeutic touch techniques and is a biofield therapy that uses life force energy to facilitate healing. Quantum-Touch was first described by Richard Gordon and Bob Rasmusson in 1978; It activates life force energy by combining various hand positions, various breathing techniques and body awareness exercises. It is applied by directing the formed high energy field to an area of pain, stress or illness through therapeutic touch. Tully (2017) found that Quantum Touch in reducing acute and chronic pain; Walton (2011) reported that Quantum-Touch application is effective in chronic musculoskeletal pain. The patient and/or the patient's family may be physically ready for relocation in the hospital environment, but they are not psychologically ready. Inadequate preparation of the individual for the transfer from the emergency room to the clinic or lack of information about the transfer, perceiving that his safety is under threat, and experiencing uncertainty about his situation cause transfer anxiety. Although it is seen in the literature that transfer anxiety is applied in adults and generally in intensive care units, no study has been found in children and emergency services.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Child, Only, Emergencies

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group, randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quantum Touch
Arm Type
Experimental
Arm Description
Those who are planned to be hospitalized from the emergency department and applied quantum touch
Arm Title
Control
Arm Type
No Intervention
Arm Description
Those who are planned to be hospitalized from the emergency department and who have not intervention
Intervention Type
Other
Intervention Name(s)
Quantum Touch
Intervention Description
Quantum-Touch is one of the therapeutic touch techniques, a biofield therapy that uses life force energy to facilitate healing
Primary Outcome Measure Information:
Title
Child Fear Scale
Description
The CFS is a scale from 0 to 4, consisting of five drawn facial expressions ranging from neutral (0=no anxiety) to frightened face (4=severe anxiety).
Time Frame
6 months
Title
Child Anxiety Scale-State
Description
CAS-S is similar to a thermometer with a light bulb at the bottom and horizontal lines at intervals that go up. The scale is aimed at children between the ages of four and ten. To measure state anxiety (CAS-S), the child is asked to mark what he feels "right now".
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being between 5-10 years old (the fear scale used for children can be used for 5-10 years old) Planning hospitalization from the emergency department to the clinic Absence of any mental and/or physical health problems that would prevent communication Parents and children speak Turkish Parent and child volunteer to participate in the study. Exclusion Criteria: Being under 5 years old and over 10 years old Having any mental and/or physical health problems that prevent communication Parents and children do not agree to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eda Polat, MSc
Phone
+905415660731
Email
edda_akyol@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Özlem İbrahimoğlu, PhD
Phone
+905436195971
Email
oogutlu@gmail.com
Facility Information:
Facility Name
Istanbul Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital
City
Istanbul
State/Province
Üsküdar
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derya Kılınç, MSc
Phone
+905541334285
Email
derya0305@hotmail.com
First Name & Middle Initial & Last Name & Degree
Özlem Akkaya, Licence
Phone
+905309301467
Email
ozlemakkaya7676@gmail.co

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The authors will decide and plan among themselves.
Citations:
PubMed Identifier
32415423
Citation
Alp FY, Yucel SC. The Effect of Therapeutic Touch on the Comfort and Anxiety of Nursing Home Residents. J Relig Health. 2021 Jun;60(3):2037-2050. doi: 10.1007/s10943-020-01025-4.
Results Reference
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22995597
Citation
Busch M, Visser A, Eybrechts M, van Komen R, Oen I, Olff M, Dokter J, Boxma H. The implementation and evaluation of therapeutic touch in burn patients: an instructive experience of conducting a scientific study within a non-academic nursing setting. Patient Educ Couns. 2012 Dec;89(3):439-46. doi: 10.1016/j.pec.2012.08.012. Epub 2012 Sep 17.
Results Reference
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PubMed Identifier
24094126
Citation
Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.
Results Reference
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PubMed Identifier
12519290
Citation
McKinley S, Coote K, Stein-Parbury J. Development and testing of a Faces Scale for the assessment of anxiety in critically ill patients. J Adv Nurs. 2003 Jan;41(1):73-9. doi: 10.1046/j.1365-2648.2003.02508.x.
Results Reference
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PubMed Identifier
21806301
Citation
McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
Results Reference
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PubMed Identifier
27502814
Citation
Senderovich H, Ip ML, Berall A, Karuza J, Gordon M, Binns M, Wignarajah S, Grossman D, Dunal L. Therapeutic Touch((R)) in a geriatric Palliative Care Unit - A retrospective review. Complement Ther Clin Pract. 2016 Aug;24:134-8. doi: 10.1016/j.ctcp.2016.06.002. Epub 2016 Jun 21.
Results Reference
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PubMed Identifier
30982141
Citation
Yucel SC, Arslan GG, Bagci H. Effects of Hand Massage and Therapeutic Touch on Comfort and Anxiety Living in a Nursing Home in Turkey: A Randomized Controlled Trial. J Relig Health. 2020 Feb;59(1):351-364. doi: 10.1007/s10943-019-00813-x.
Results Reference
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PubMed Identifier
22828950
Citation
Zolfaghari M, Eybpoosh S, Hazrati M. Effects of therapeutic touch on anxiety, vital signs, and cardiac dysrhythmia in a sample of Iranian women undergoing cardiac catheterization: a quasi-experimental study. J Holist Nurs. 2012 Dec;30(4):225-34. doi: 10.1177/0898010112453325. Epub 2012 Jul 24.
Results Reference
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The Effect of "Quantum Touch" Application on Transfer Anxiety in Pediatric Patients and Their Parents Planned to be Hospitalized in the Emergency Department

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