Protocol summary

Summary
Pain is the most common physical sign, and anxiety is the most common psychological symptom in cancer patients, both have negative impact on their quality of life and need appropriate intervention. Therapeutic Touch is a noninvasive nursing intervention done by hand through energy transmission. This research is an RCT, containing 3 groups of control, interventional, and placebo. The purpose of this study is to investigate the effect of therapeutic touch on pain and anxiety in cancer patients. Patients will be randomly assigned to three groups: intervention, placebo, and control group. Inclusion criteria: Male patients with cancer (without central nervous system metastasis); aged 20 to 65 years; with history of cancer at least for one year. Exclusion criterion: Unwillingness to continue participation in the study; not being able to complete the treatment sessions for any reason. In intervention group, participants will receive 7 sessions of therapeutic touch (healing energy) for 15 minutes; in placebo group, participants will receive sham therapeutic touch; and in control group, patients will receive routine treatment. Instruments include Brief Pain Inventory, Zung Self-rating Anxiety Scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201412094115N3
Registration date: 2015-01-01, 1393/10/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-01, 1393/10/11
Registrant information
Name
Amir Tabatabaee
Name of organization / entity
Islamic Azad University- Quchan Branch
Country
Iran (Islamic Republic of)
Phone
+98 51 3726 2676
Email address
tabatabaee_amir@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of therapeutic touch on pain and anxiety in patients with cancer
Public title
Effect of therapeutic touch on pain and anxiety in patients with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent of participants; male patients aged 20 to 65 years; Being conscious; cancer-related pain confirmed by physician; being diagnosed and treated at least for one year; possessing full consciousness and mental health; no history of depression and anxiety before the diagnosis; being in remission stage; no plan for surgery as treatment; no history of using therapeutic touch. Exclusion criteria: Unwillingness to continue participation in the study; use of other methods of alternative medicine during study; need for surgery and invasive diagnostic procedures during study; painful events (accident, acute illness) leading to stress and anxiety during the study; marked change in the dosage of pain medication used (ordered by the physician or by the patient); deterioration of patient health status leading to inability to continue the treatment.
Age
From 20 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
study have three group. control, intervention, placebo

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
ghorshi build, Daneshgah st.
City
Mashhad
Postal code
9185757976
Approval date
2014-10-25, 1393/08/03
Ethics committee reference number
93101

Health conditions studied

1

Description of health condition studied
Malignant neoplasms
ICD-10 code
C00-D48
ICD-10 code description
Malignant neoplasms

Primary outcomes

1

Description
pain
Timepoint
Before and after intervention, after 7th section
Method of measurement
Brief Pain Inventory(BPI)

2

Description
Anxiety
Timepoint
Before and after intervention, 4th section
Method of measurement
Zungs Self rating Anxiety Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Implementation of therapeutic touch for 15 min
Category
Other

2

Description
Placebo group: Implementation mimic therapeutic touch, hands hold far from patients body. This do to unification placebo and intervention group.
Category
Other

3

Description
Control group: routine treatment without intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Mashhad Hospital
Full name of responsible person
Dr. Sayeed Amir Aldavood
Street address
Omid Hospital, Kuhsangi st.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
International Branch of Behesti University of Medical Sciences
Full name of responsible person
Keyandokhte Ghanati
Street address
19 Shahid Abbaspour st., Vali- Asr Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Branch of Behesti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
International Branch of Behesti University of Medical Sciences
Full name of responsible person
Amir Tabatabaee
Position
Student of PhD
Other areas of specialty/work
Street address
19 Shahid Abasspour st., Vali-Asr Ave.
City
Tehran
Postal code
Phone
+98 21 8820 9020
Fax
+98 21 8864 9181
Email
tabatabaei.amir@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing School, Behesti University of Medical Sciences
Full name of responsible person
Mansoreh Zaghari Tafreshi
Position
PhD in Nursing
Other areas of specialty/work
Street address
Neyaesh, Valiasr St.
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
tafreshi45@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing Department, Quchan Branch,Islamic Azad University
Full name of responsible person
Amir Tabatabaee
Position
Student in PhD
Other areas of specialty/work
Street address
Quchan Branch, Islamic Azad University
City
Quchan
Postal code
Phone
+98 51 3726 2676
Fax
+98 51 4701 1294
Email
tabatabaei.amir@gmil.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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