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AnxietyNCT05380466

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

A study testing Quantum Touch in people with Anxiety and Child, Only, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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". Read more about this study

Who is it for?
Ages 5 to 10 years
Conditions the study is for
Anxiety, Child, Only, Emergencies
What is being tested?
Quantum Touch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2022to 1 Aug 2024
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 5 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital

    Istanbul, Üsküdar

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
Quantum Touch
Medical subject headings
Anxiety Disorders, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quantum TouchOther

    Quantum-Touch is one of the therapeutic touch techniques, a biofield therapy that uses life force energy to facilitate healing

Study groups in NCT05380466
Study groupRoleWhat they receive
Quantum TouchExperimentalThose who are planned to be hospitalized from the emergency department and applied quantum touch
Receives: Other: Quantum Touch
ControlNo interventionThose who are planned to be hospitalized from the emergency department and who have not intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 months

  2. 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".

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start1 Mar 2022
  3. Primary completion1 Jun 2024
  4. Study completion1 Aug 2024

Resources

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
Parallel group, randomized controlled study
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05380466
Sponsor's protocol ID
IstanbulMU16
Status last verified
Sep 2024
First submitted
13 May 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The authors will decide and plan among themselves.

Publications

  • 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.

    PubMed 32415423
  • 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.

    PubMed 22995597
  • 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.

    PubMed 24094126
  • 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.

    PubMed 12519290
  • 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.

    PubMed 21806301
  • 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.

    PubMed 27502814
  • 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.

    PubMed 30982141
  • 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.

    PubMed 22828950

Questions about this trial

What is this clinical trial studying?

A study testing Quantum Touch in people with Anxiety and Child, Only, run by Istanbul Medeniyet University 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Fear Scale (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05380466, which also lists 8 linked publications.

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 19 Sep 2024.

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