A comparison between the effects of application versus non-application of foot reflexology massage on stress and neuropathic pain induced by chemotherapy in women with breast cancer and genital organs
This clinical trial investigates the effect of foot reflexology massage on stress and neuropathic pain induced by chemotherapy in women with breast and genital tract cancer. The study is performed in one center and without blindness. Major inclusion criteria include female patients aged 18 to 60 years; definitive diagnosis of breast cancer; and having a pain score of 12 or more in Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale. Major exclusion criteria include metastatic conditions for bone marrow, lung, liver and kidneys; and lack of patient collaboration until the end of the intervention. Participants will be selected from the Iranmehr Health Center, affiliated with Birjand University of Medical Sciences via convenience sampling method. They will be randomly assigned into intervention (n=30) and control (n=30) groups. Prior to the intervention, demographic characteristics form, Perceived Stress Scale (Cohen et al., 1983), and the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale will be completed by both groups. The intervention group will receive foot reflexology massage for two weeks, but the control group will not receive any intervention. Two weeks after the end of intervention, the groups will complete the two scales for a second round. The scores obtained in the two administrations of the scales by the groups will be compared whereby the effect of foot reflexology massage on stress and neuropathic pain will be determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017090517756N28
Registration date:2017-09-19, 1396/06/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery for Research of Birjand University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2018-02-04, 1396/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the effects of application versus non-application of foot reflexology massage on stress and neuropathic pain induced by chemotherapy in women with breast cancer and genital organs
Public title
The effect of foot reflexology massage on stress and neuropathic pain induced by chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Definitive diagnosis of breast cancer; malignancy based on pathological studies, clinical findings, and physician diagnosis; women treated with Taxon; age between 18 and 60 years; neuropathic pain induced by chemotherapy with a score of 12 or more according to the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale; reading and writing literacy and the ability to speak for the patient or caregiver; having healthy limbs in the legs, especially the sole of the legs or lack of sensory and motor disorders; no drug abuse; non-use of psychotropic drugs; no history of mental illness; informed consent for participation; and the use of prophylaxis drugs for neuropathic pains such as gabapentin and pre-cabalin.
Exclusion criteria: Metastasis for bone marrow, lung, liver and kidneys; patient's lack of cooperation until the end of the intervention; and the presence of stressors such as the death of first-degree relatives, divorce, and severe changes in lifestyle over the past 6 months.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice-chancellery for Research, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Approval date
2017-05-01, 1396/02/11
Ethics committee reference number
ir.bums.REC.1396.96
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
D05
ICD-10 code description
Carcinoma in situ of breast
2
Description of health condition studied
Genital tract cancer
ICD-10 code
C57.9
ICD-10 code description
Female genital organ, unspecified
Primary outcomes
1
Description
Perceived stress
Timepoint
before intervention and 2 weeks after intervention is completed
Method of measurement
Cohen et al.’s Perceived Stress Scale
2
Description
Neuropathic pain severity
Timepoint
before intervention and 2 weeks after intervention is completed
Method of measurement
The Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group (Foot reflexology message): Prior to the intervention, demographic characteristics form, Perceived Stress Scale (Cohen et al., 1983), and the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale will be completed by the group. The intervention group will receive foot reflexology massage for two weeks. Two weeks after the end of intervention, the group will complete the two scales for a second round.
Category
Other
2
Description
Control Group (No intervention): Prior to the intervention, demographic characteristics form, Perceived Stress Scale (Cohen et al., 1983), and the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale will be completed by the group. The control group will not receive any intervention. Two weeks after the end of intervention, the group will complete the two scales for a second round.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranmehr Chemotherapy Center
Full name of responsible person
Dr Ahmadreza Sebzari
Street address
Ghafari Street,
City
Birjand,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellery for Research, Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Vice chancellery for Research, Birjand University of Medical Sciences, Ayatollah Ghafari Street,
City
Birjand,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery for Research, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Seyed Hosain Rezaei Mohebbati
Position
M.Sc. Student of Nursing
Other areas of specialty/work
Street address
Alley No. 16., Janbazan Blvd.,
City
Boshrouyeh
Postal code
Phone
+56 32224687
Fax
Email
SHRM37@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tayebeh Khazaei
Position
Instructor
Other areas of specialty/work
Street address
Faculty of Nursing, Birjand University of Medical Sciences, Ayatollah Ghaffari Street,
City
Birjand,
Postal code
Phone
+98 56 3238 1433
Fax
Email
thayebehk@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
roozgar@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)