NCT05380466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.3 years

First QC Date

May 13, 2022

Last Update Submit

September 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    6 months

  • 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".

    6 months

Study Arms (2)

Quantum Touch

EXPERIMENTAL

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

Other: Quantum Touch

Control

NO INTERVENTION

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

Interventions

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

Quantum Touch

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 32415423BACKGROUND
  • 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.

    PMID: 22995597BACKGROUND
  • 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.

    PMID: 24094126BACKGROUND
  • 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.

    PMID: 12519290BACKGROUND
  • 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.

    PMID: 21806301BACKGROUND
  • 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.

    PMID: 27502814BACKGROUND
  • 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.

    PMID: 30982141BACKGROUND
  • 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.

    PMID: 22828950BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersEmergencies

Condition Hierarchy (Ancestors)

Mental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel group, randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 18, 2022

Study Start

March 1, 2022

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations