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

March 5, 2024 updated by: Eda Polat, Istanbul Medeniyet University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Özlem İbrahimoğlu, PhD
  • Phone Number: +905436195971
  • Email: oogutlu@gmail.com

Study Locations

  • Turkey
    • Üsküdar
      • Istanbul, Üsküdar, Turkey
        • Recruiting
        • Istanbul Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Quantum Touch
Those who are planned to be hospitalized from the emergency department and applied quantum touch
Other: Quantum Touch
Quantum-Touch is one of the therapeutic touch techniques, a biofield therapy that uses life force energy to facilitate healing
No Intervention: Control
Those who are planned to be hospitalized from the emergency department and who have not intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child Fear Scale
Time Frame: 6 months
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).
6 months
Child Anxiety Scale-State
Time Frame: 6 months
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".
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medeniyet University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Science University Zeynep Kamil Women and Children's Disease Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IstanbulMU16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The authors will decide and plan among themselves.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings