Effect of acupressure on fatigue and anxiety in the patients with cancer: single-blind randomized clinical trial in three groups (intervention, placebo and control)
Objective: effect of acupressure on fatigue and anxiety in the patients with cancer. Design: a single-blind randomized clinical trial. Setting and conduct: the patients with cancer in hematology unit will be included in the study with the following criteria: (a) II, III, and IV stages of cancer; (b) consciousness; (c) lack of amputation or ulcer at acupoints; (d) lack of sever heart failure; (e) lack of hypothyroidism; (f) lack of coagulant disorders. The patients will be excluded from the study with the following criteria: (a) hemoglobin less than nine gram per deciliter; (b) platelet less than 50000 per microliter; (c) pregnancy. Intervention: in the intervention group acupressure will be conducted on the fifteen correct acupoints in the ten sessions for half an hour during two weeks. In the placebo group acupressure will be conducted on the fifteen sham acupoints close to correct acupoints in the ten sessions for half an hour during two weeks. In the control group the patients will be received only routine cares. Main outcome measures: fatigue and anxiety will be assessed with questionnaires as following: (a) fatigue will be assessed with the Brief Fatigue Inventory questionnaire before intervention, before the sixth session of intervention and after the tenth session of intervention; (b) anxiety will be assessed with the Spielberger anxiety questionnaire before the intervention, before the sixth session of intervention and after the tenth session of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301219759N2
Registration date:2013-02-12, 1391/11/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-12, 1391/11/24
Registrant information
Name
Ali Bikmoradi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0439
Email address
bikmoradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-02-08, 1391/11/20
Expected recruitment end date
2013-05-10, 1392/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupressure on fatigue and anxiety in the patients with cancer: single-blind randomized clinical trial in three groups (intervention, placebo and control)
Public title
Effect of acupressure on fatigue and anxiety in the patients with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
The patients with cancer in hematology unit will be included in the study with following criteria: (a) II, III, and IV stages of cancer; (b) consciousness; (c) lack of amputation or ulcer at the acupoints; (d) lack of sever heart failure; (e) lack of hypothyroidism; (f) lack of coagulant disorders. The patients will be excluded from the study with the following criteria: (a) hemoglobin less than nine gram per deciliter; (b) platelet less than 50000 per microliter; (c) pregnancy.
Age
From 18 years old to 64 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, the balanced block randomization will be used and the patients allocated in three groups; intervention group (acupressure on the correct acupoints), placebo group (acupressure on the sham acupoints) and control group (routine cares). Acupressure will be conducted (as single-blind) on the correct and sham acupoints in two groups of intervention and placebo. So the patients will be not informed about the kind of acupressure.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Human Subject Review Board of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838698
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
D/P/16/35/9/3496
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.3
ICD-10 code description
Other mixed anxiety disorders
2
Description of health condition studied
Cancer
ICD-10 code
C00, C01,
ICD-10 code description
Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue
3
Description of health condition studied
Cancer
ICD-10 code
C76, C77,
ICD-10 code description
Malignant neoplasms of ill-defined, secondary and unspecified sites
4
Description of health condition studied
Cancer
ICD-10 code
C97
ICD-10 code description
Malignant neoplasms of independent (primary) multiple sites
5
Description of health condition studied
Cancer
ICD-10 code
D00, D01,
ICD-10 code description
In situ neoplasms
6
Description of health condition studied
Cancer
ICD-10 code
D37, D38,
ICD-10 code description
Neoplasms of uncertain or unknown behaviour
7
Description of health condition studied
Fatigue
ICD-10 code
R53
ICD-10 code description
Malaise and fatigue
8
Description of health condition studied
Cancer
ICD-10 code
C81, C82,
ICD-10 code description
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
Primary outcomes
1
Description
Fatigue
Timepoint
Before intervention, before the sixth session of intervention and after the tenth session of intervention
Method of measurement
Brief Fatigue Inventory questionnaire
2
Description
Anxiety
Timepoint
Before intervention, before the sixth session of intervention and after the tenth session of intervention
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the intervention group acupressure will be conducted on the fifteen correct acupoints in ten sessions for half an hour during two weeks.
Category
Treatment - Other
2
Description
Placebo group: in the placebo group acupressure will be conducted on the fifteen sham acupoints close to correct acupoints in the ten sessions for half an hour during two weeks.
Category
Treatment - Other
3
Description
Control group: in the control group the patients will be received only routine cares.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Therapeutic and Educational Center of Hamadan
Full name of responsible person
Fatemeh Najafi
Street address
Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Tavilani
Street address
Vice-Chancellor of Research and Technology, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Grant name
از محل یک درصد بودجه طرح های تحقیقاتی دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor of Research and Technology, Hamadan 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
Department of Medical Surgical Nursing
Full name of responsible person
Dr. Ali Bikmoradi
Position
Medical Education Management
Other areas of specialty/work
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838698
Phone
+98 81 1838 0439
Fax
+98 81 1838 0447
Email
bikmoradi@umsha.ac.ir; abeikmoradi@yahoo.com
Web page address
www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Medical Surgical Nursing
Full name of responsible person
Dr. Ali Bikmoradi
Position
Medical Education Management
Other areas of specialty/work
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmide Ave.
City
Hamadan
Postal code
6517838698
Phone
+98 81 1838 0439
Fax
+98 81 1838 0447
Email
bikmoradi@umsha.ac.ir; abeikmoradi@yahoo.com
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Department of Medical Surgical Nursing
Full name of responsible person
Dr. Ali Bikmorad
Position
Medical Education Management
Other areas of specialty/work
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838698
Phone
+98 81 1838 0439
Fax
+98 81 1838 0447
Email
bikmoradi@umsha.ac.ir; abeikmoradi@yahoo.com
Web page address
www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)