NCT06487182

Brief Summary

The aim of this study is to determine the effect of Reiki applied to mothers whose children were treated in the hospital on the anxiety level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Jun 2024

Shorter than P25 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

First Submitted

Initial submission to the registry

June 27, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

June 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2024

Completed
Last Updated

January 22, 2025

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

June 27, 2024

Last Update Submit

January 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • anxiety

    The State Anxiety Scale assesses feelings of fear, tension, irritability, and anxiety that increase during stress in response to physical danger and psychological stress. The 20-question test allows individuals to answer within 10 minutes. It provides answers on a four-point Likert type scale. STAI, reliability ranging from 0.83 to 0.92 It has sufficient validity and reliability with its coefficients (Vitale 2006).

    immediately before reiki application and immediately after the reiki application]

Study Arms (3)

Reiki

EXPERIMENTAL

The intervention will be applied to the reiki group in the application hospital room. Reiki therapy will be applied by a practitioner with a Reiki application certificate in the application laboratory for 30 minutes while the participants lie down with their eyes closed. 4 sessions of reiki application will be applied to the intervention group for a week. Reiki application will start , the first anxiety scores will be recorded. Anxiety levels after 4 sessions will be recorded.

Other: reiki

Placebo reiki

SHAM COMPARATOR

Placebo Reiki will be applied to the participants in the group in the application hospital room. The practice will be carried out in the application room for 30 minutes, with the participants sitting with their eyes closed. Reiki life energy will not be transferred to participants in the placebo reiki group. Since the participants' eyes are closed, they will not know that there is a transfer. Placebo Reiki application will be performed in the room 4 times during a week. Placebo application will start and the anxiety scores will be recorded. After 4 sessions, anxiety scores will be recorded.

Other: placebo reiki

control

NO INTERVENTION

Routine hospital procedure will be applied. Anxiety scores will be recorded. After a week anxiety scores will be recorded.

Interventions

reikiOTHER

reiki

Also known as: control group, placebo reiki
Reiki

placebo reiki

Also known as: control group
Placebo reiki

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least the 3rd day of hospitalization
  • Their child has an acute or chronic disease
  • Able to speak and write Turkish and have no communication problems
  • No psychiatric history and not using medication
  • Not drinking alcohol in the last 24 hours
  • Those who have not received body-mind therapy (yoga, reiki, massage, meditation) in the last six months
  • Mothers who volunteer to participate in the research will be included.

You may not qualify if:

  • Reiki practitioner or who also has an instructor
  • Having time and communication problems that cannot answer the questions asked
  • Mothers who do not volunteer to participate in the study will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Therapeutic TouchControl Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sümeyye BAL, Ph.D.

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 5, 2024

Study Start

June 30, 2024

Primary Completion

November 10, 2024

Study Completion

November 10, 2024

Last Updated

January 22, 2025

Record last verified: 2024-10

Locations