This research will be conducted to determine the effects of reflexology on intensity of pain and anxiety in 92 metastatic cancer patients at the Adult Hematology Ward in Shafa Hospital of Ahvaz. The patients will be selected based on the inclusion criteria and then randomly divided into the intervention and control groups. In the intervention group, the manual reflexology method will be applied by the researcher in the patients’ rooms in a private atmosphere following the reflexology protocol. Reflexology will be carried out in 30-minute sessions for three days. The first five minutes will be in the form of massaging for relaxation. It will be followed by 15 minutes of reflexology on the reflex points of the patient’s body where pain is felt, five minutes of reflexology all over the body to make sure the whole body receives the reflexology treatment, and the last five minutes will be dedicated to relaxation massage again. In the control group, in addition to the usual care the patients receive in the ward, which includes drug treatments and administration of pain killers, the skin on the entire soles of their feet will be used as a placebo for blinding the inductive effects of reflexology. Finally, after the three days, the VAS Questionnaire for Pain and Spielberger’s State-Trait Anxiety Questionnaire will be given to the subjects again to be filled by them.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061634381N2
Registration date:2017-07-01, 1396/04/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-01, 1396/04/10
Registrant information
Name
Ferdos Pelarak
Name of organization / entity
Dezful Azad University
Country
Iran (Islamic Republic of)
Phone
+98 916 941 7091
Email address
pelarak.f@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of reflexology on pain intensity and anxiety in metastatic cancer patients admitted in adult hematology
Public title
Effect of reflexology on pain intensity and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients with metastatic cancer pain higher than 3 on VAS pain scale; Awareness of time, place and person; The lack of peripheral neuropathy; No risk of venous thrombosis; No defects foot; Having anxiety higher than 21 on the scale Eshpel Burgers; The absence of open wounds, particularly on the reflex points.
Exclusion criteria: The patient is ill or died during the study; loss of consciousness during the study.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
6135715794
Approval date
2016-12-03, 1395/09/13
Ethics committee reference number
IR.AJUMS.REC.1395.669
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
C79.9
ICD-10 code description
Secondary malignant neoplasm, unspecified site
Primary outcomes
1
Description
pain
Timepoint
Before intervention and after intervention
Method of measurement
Visual analuge scale
Secondary outcomes
1
Description
anxiety
Timepoint
Before intervention and after intervention
Method of measurement
Spielberger anxiety inventory
Intervention groups
1
Description
In the intervention group reflexology during three days and will be done every day for 30 minutes. The first 5 minutes in the form of massage for relaxation, a 15-minute reflexology in the reflection of the patient who is in pain, a 5-minute reflexology in all areas to ensure that the entire body is covered, 5 minutes later, again in the form of massage for relaxation do will be.
Category
Other
2
Description
The control group in addition to usual care, including medical treatment and housing back foot skin disease as blind placebo for induction effect of reflexology will be used.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital Hematology
Full name of responsible person
Simin Jahani
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmal Zadeh
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Simin Jahani
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3292 1839
Fax
Email
Jahanisimin50@yahoo.com
Web page address
www.ajuma.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Simin Jahani
Position
phd Nursing
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences-School of Medicine
City
Ahvaz
Postal code
Phone
+98 61 3292 1839
Fax
Email
Jahanisimin50@yahoo.com
Web page address
www.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Ferdos Pelarak
Position
Other areas of specialty/work
Street address
City
Postal code
00
Phone
+98 61 3292 1839
Fax
Email
f.pelarak20@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)