The Effect of Foot Reflexology on The Quality of Sleep in Cancer Patients Selected Hospital
Design
Two arm parallel group randomised trial nonblinded preoperative then postoperative care and outcome assessment
Settings and conduct
Initially, using patient files in the chemotherapy department, evaluated the patients who first completed their chemotherapy and considered the criteria for entering the study.Then, the qualified samples will be taken after explaining the goals of the study, the importance of the research and the process of the study, written consent and informed consent. After considering the criteria for entry and non entry, among the samples of this study, 60 patients with pancreatic cancer are selected. patients with a sleep score of 5 and above of the Pittsburgh questionnaire were isolated and the research samples were randomly assigned to women and men by using numbering records and then selecting paired numbers. the test group and the individual numbers will be selected as the control group
Participants/Inclusion and exclusion criteria
inclusion criterion for research
Patients with primary colorectal cancer
Patient admitted to chemotherapy for the first time
Earn score 5 and above Pittsburgh Sleep Quality Index
No history of taking medications
Lack of leg problems and problems such as leg deformity
No use of herbal or chemical drugs during research to improve sleep
Aged 18 years and over
Non entry criteria for research
Unwillingness to continue to participate during the trial
Having any complications and illness in the patient's legs during the study
Early discharge of the patient
Intervention groups
In the intervention group, subjects received foot massage for every 10 minutes for each leg for two consecutive days every two weeks.
The control group did not receive any intervention and received only the usual care from the center
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170730035394N2
Registration date:2018-04-25, 1397/02/05
Registration timing:retrospective
Last update:2018-04-25, 1397/02/05
Update count:0
Registration date
2018-04-25, 1397/02/05
Registrant information
Name
Behnam Abedini
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 935 928 0808
Email address
behnamabedini94@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
According to university regulations
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Foot Reflexology on The Quality of Sleep in Cancer Patients Selected Hospital at Shahid Beheshti University of Medical Sciences
Public title
The Effect of Foot Reflexology on Sleep in Cancer Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with primary colorectal
cancer Patient admitted to chemotherapy for the first time
Earn score 5 and above Pittsburgh Sleepwick Inventory
According to seven pittsburgh standards
there is a problem with sleep quality
Not having mental or psychological problems or mental problems
Lack of diabetes
Lack of leg problems and problems such as leg deformity
No use of herbal or chemical drugs during research to improve sleep
Aged 18 and over
Exclusion criteria:
Unwillingness to continue to participate during the trial
Cause of any complications and illness in the patient's legs during the study
Early discharge of the patient
Acute infectious diseases during the study
Age
From 18 years old to 99 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
The sampling method for the study is simple random sampling method and is randomly assigned to the sequencing by blocking method and randomly divided into intervention and control groups.
It should be noted that the method of hiding using the central randomization method (Central randomization). In this method, the random sequence is given to one
A person is taken and samples are taken in the oncology department of the hospital. The researcher will communicate with the relevant department using the telephone, according to the order of entry of participants to the study and ask about the random allocation of the participant to the specific group.
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 committe of Shahid Beheshti University of Medical Sciences
Street address
SBMU School of Nursing & Midwifery, Vali Asr Ave, Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.SBMU.PHNM.1396.756
Health conditions studied
1
Description of health condition studied
colon cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
2
Description of health condition studied
Rectum cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
3
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Quality of sleep or Earn score 5 and above Pittsburgh Sleep quality index
Timepoint
Before intervention and immediately after intervention
Method of measurement
pittsburgh sleep quality index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: There are 4 reflexology massage courses, each course including two sessions in two consecutive days and intervals of each period of 2 weeks, which will last from 2 months to the end of the intervention.
Category
Treatment - Other
2
Description
Control group: Receive routine care from the center
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Mahnaz Ilkhani
Street address
Imam Hossein Hospital, Shahid Madani Avenue, Nezam Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
behnamabedini94@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahrokh Dolatian
Street address
SBMU School of Nursing & Midwifery, Vali Asr Ave, Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Email
behnamabedini94@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behnam Abedini
Position
Master's Degree Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 25 3886 3342
Fax
Email
behnamabedini94@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Ilkhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali Asr Ave, Niayesh Cross Road, Niayesh Complex, Tehran, Iran