Effect of Emotional Freedom Technique on Quality of Life in colorectal cancer undergoing chemotherapy
Design
Clinical trials with two control and intervention group, blocked randomisation method is used,the number of samples in both group is 30 patients without blinding
Settings and conduct
This study was conducted in Shahid Qhazi Tabatabai Hospital affiliated to Tabriz University of Medical sciences. Patients with colorectal cancer were selected base on the exclusion and inclusion criteria, Emotional Freedom Technique is performed in the intervention group. The control group received routine care only, in this study , blinding was not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with primary colorectal cancer and experience of first chemotherapy, exclusion criteria: absence of mental and physical diseases
Intervention groups
The intervention group: in this group، in addition to routine interventions, Emotional Freedom Technique is performed in this way that the pressure areas are selected to perform the technique.These pressure areas are tapped with the fingertips for 20 to 60 minutes at the patient bedside in a private room.
The control group: This group receives only the routine interventions that include chemotherapy and nursing care
Main outcome variables
Quality of Life in colorectal cancer patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141112019919N9
Registration date:2025-03-11, 1403/12/21
Registration timing:prospective
Last update:2025-03-11, 1403/12/21
Update count:0
Registration date
2025-03-11, 1403/12/21
Registrant information
Name
Arefeh Davoodi Bavil Oliaii
Name of organization / entity
Nursing and Midwifery of Faculty, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0648
Email address
adavoodi@tbzmed.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-03, 1404/01/14
Expected recruitment end date
2026-03-20, 1404/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Emotional Freedom Technique on Quality of Life in patients with colorectal cancer undergoing chemotherapy: Clinical trial study.
Public title
Effect of Emotional Freedom Technique on Quality of Life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Interested in participating in study
Informing the patient about his/her illness
Having primary colorectal cancer
Having the first experience of chemotherapy
Ability to communication and learning
Exclusion criteria:
The occurrence of unfortunate events in the last 6 months: divorce,death of family or spouse
Mental illness and neurological disorders
Presence of heart, kidney,glandular and liver diseases
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign patients to the intervention and control groups, the blocked randomisation method will be used with blocks of 4 and 6 and with an allocation ratio of 1:1. Allocation of the patients to the groups will be done by a non collaborator in the research project. In order to allocation concealment the type of intervention will be written on paper and placed inside opaque envelopes numbered consecutively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The control group received the routine treatments of the ward, the intervention group besides routine treatments, learn and perform Emotional Freedom Technique.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical sciences
Street address
South Shariati Street, Faculty of nursing and midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2023-01-09, 1401/10/19
Ethics committee reference number
IR.TBZMED.REC.1401.924
Health conditions studied
1
Description of health condition studied
Colorectal cancer
ICD-10 code
C18.9
ICD-10 code description
Malignant neoplasm of colon, unspecified
Primary outcomes
1
Description
The quality of Life scores based on QLQ_ C30 and QLQ_CR29 questioners.
Timepoint
Before the start of intervention and two months after the intervention
Method of measurement
Quality of Life questioner in Cancer patients and quality of life questioner in colorectal cancer
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" This intervention will be performed in the four courses of chemotherapy, each course lasting three days.The resercher will performed EFT technique on the patients in the morning time for 20 to 60 minutes.The desired pressure areas for performing the EFT technique included the tip of the head, the bigining of the eyebrow, the outer side of the eye, under the eye, under the nose, chin, sternum, four inches below the armpit, the outer side of the back of the hand. For effectiveness of EFT technique the patient was transferred to the privet room in the ward, and all of the hygiene points was observed at the patients bedside.
Category
Rehabilitation
2
Description
"Control group:" The control group receives only routine interventions of the ward. Routine interventions include nursing care and medical team care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ghazi Hospital and Shahid Madani Hospital in Tabriz.
Full name of responsible person
Arefeh Davoodi
Street address
Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 0648
Email
Adavoodi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arefeh Davoodi
Street address
Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 0648
Email
nursing@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arefeh Davoodi
Position
Educator of nursing، Academic member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 0648
Email
adavoodi@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arefeh Davoodi
Position
Academic member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 0648
Email
adavoodi@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arefeh Davoodi
Position
Academic member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 0648
Email
adavoodi@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
,_
When the data will become available and for how long
_
To whom data/document is available
_
Under which criteria data/document could be used
_
From where data/document is obtainable
_
What processes are involved for a request to access data/document