NCT04935723

Brief Summary

Abdominal surgeries are those in which pain is felt severely due to the incision close to the diaphragm and an intensive neural network in the abdominal area. If the patient's post-operative pain is not controlled; Since it will restrict patient mobility, it can cause problems on many systems such as the pulmonary, cardiovascular and neuroendocrine system, and even suppress the immune system. Surgical intervention decision can cause anxiety in individuals regardless of the type of surgical procedure. Fear of anesthesia, fear of death, possibility of developing complications after surgery, pain, change in daily life activities, loss of social life and loss of control can lead to anxiety. In addition to all these, factors such as pain, fear, anxiety that stimulate the sympathetic nervous system can increase the pulse rate, blood pressure and respiratory rate. Reiki, a complementary and alternative medicine (TAT) method, is a bioenergy based on the energy use of the body and has been used in various cultures for centuries in preventing and treating some diseases. Reiki is thought to help balance the body's natural energetic systems and reduce anxiety by transferring the available energy through hands. During Reiki, the activity of the parasympathetic system increases, pain and anxiety decrease. Thus, the patient's complaints are reduced by providing early discharge with possible complications after surgery. Studies on the effectiveness of reiki, which is increasing worldwide use and recommended as a treatment approach for health services, are insufficient. The aim of this study, which is planned as a three-group interventional randomized control, is to examine the effect of reiki application on patients' negative reflections on pain, anxiety, fear and vital signs, which is the major surgery type in which patients experience the most pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Jun 2020

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

Study Start

First participant enrolled

June 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

June 10, 2021

Last Update Submit

March 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Change of anxiety, fear, postoperative pain and vital signs of Reiki application before and after application.

    0-2 day

Study Arms (3)

EFFECT OF REIKIN ON ANXIETY, FEAR, PAIN AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS

EXPERIMENTAL

According to randomization, the patients in the reiki/sham reiki group were taken to a quiet single room and reiki/sham reiki was applied for approximately 25-30 minutes. will be applied. Reiki application will be applied by a researcher who has Reiki I and Reiki II level training.

Other: Reiki

EFFECT OF SHAM REIKIN ON ANXIETY, FEAR, PAIN AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS

PLACEBO COMPARATOR

According to randomization, the patients in the sham reiki group were taken to a quiet single room and sham reiki was applied for approximately 25-30 minutes. will be applied. Sham Reiki will be applied by a health professional who has not received Reiki training.

Other: Reiki

ANXIETY, FEAR PAIN LEVELS AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS

NO INTERVENTION

The control group will be given routine post-operative care without any intervention and the data collection tools will be applied at the same time as the experimental group, twice at 30-minute intervals.

Interventions

ReikiOTHER

The study was conducted as a three-group interventional randomized controlled trial to examine the effect of Reiki touch therapy on surgical fear, pain, anxiety and vital signs in patients undergoing open abdominal surgery. Reiki was applied to the first group and sham reiki to the second group. Group 3 formed the control group.

EFFECT OF REIKIN ON ANXIETY, FEAR, PAIN AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTSEFFECT OF SHAM REIKIN ON ANXIETY, FEAR, PAIN AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No vision-hearing problems Able to communicate verbally No diagnosed psychologist problems Has past or present don't use of substances who will receive general anesthesia, ASA I, II and III, Elective open abdominal surgery,

You may not qualify if:

  • Patient Controlled Analgesia (PCA) use Those who have previously taken energy therapies such as Reiki Touch Therapy / Therapeutic Touch / Healing Touch who have had previous abdominal surgery,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain, Postoperative

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Mental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Sevban Arslan, Phd

    Çukurova University Faculty of Health Sciences Adana, Turkey

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients who will form the experimental group will not be told which method (reiki, sham reiki) will be applied.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was planned as a three-group interventional randomized controlled study to examine the effect of Reiki touch therapy, which is a complementary method in relieving surgical fear, pain and anxiety in patients who will undergo open abdominal surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator.

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 23, 2021

Study Start

June 15, 2020

Primary Completion

November 20, 2020

Study Completion

December 25, 2020

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations