Protocol summary
-
Study aim
-
Comparing the effect of floating feet in warm water and foot reflexology on fatigue and sleep quality in patients under radiotherapy
-
Design
-
This study has two intervention groups. Simulation is performed by ssps software. The sample size in each group was 30 patients.The plan is a parallel
And it's kind of a currency trial.
-
Settings and conduct
-
This study is performed on patients undergoing radiotherapy at Reza Sanatorium
-
Participants/Inclusion and exclusion criteria
-
1. To perform radiotherapy, refer to the center of Imam Reza Mashhad
2. Age is between 18 and 60 years old
3. Be alert
4. Stage cancer is zero, one, two or three, and non-metastatic
5. There is no peripheral vascular disease, ulcers, infection or cancer and foot radiotherapy and peripheral sensory loss
6. Do not use hypnotic and sedative drugs
7. The phone number has been provided to the researcher for follow up
8. At the same time, chemotherapy and other therapies, including hormone therapy,Target therapy, are not used
9. In response to the Smith's Fatigue Questionnaire, earns a score of 30 and above
10. In response to the Pittsburgh Sleep Quality Questionnaire, earns a score of 5 and above
-
Intervention groups
-
Intervention group1: In the group of floating legs in warm water, patients from the seventh day after starting radiotherapy every night for 2 weeks float their legs 10 cm above the wrist in water (41 to 42 ° C) for 20 minutes Inside the plastic container with a size of 40 × 27 × 45
Intervention group2: The intervention is performed within 2 weeks of the seventh day after radiotherapy is initiated every night for 10 minutes per foot. Reflexology intervention outcomes include preparation, warm-up and massage and stimulation techniques performed at the point of the solar plexus and the pituitary gland and pineal gland located on the soles of the toe
-
Main outcome variables
-
The amount of fatigue, Sleep Quality Score
General information
-
Reason for update
-
Termination of clinical trial
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20190625044009N1
Registration date:
2019-08-26, 1398/06/04
Registration timing:
prospective
Last update:
2024-04-09, 1403/01/21
Update count:
2
-
Registration date
-
2019-08-26, 1398/06/04
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-08-11, 1398/05/20
-
Expected recruitment end date
-
2019-10-12, 1398/07/20
-
Actual recruitment start date
-
2019-08-31, 1398/06/09
-
Actual recruitment end date
-
2019-12-19, 1398/09/28
-
Trial completion date
-
2019-12-29, 1398/10/08
-
Scientific title
-
Comparing the effect of floating feet in warm water and foot reflexology on fatigue and sleep quality in patients under radiotherapy
-
Public title
-
Comparing the effect of floating feet in warm water and foot reflexology on fatigue and sleep quality in patients under radiotherapy
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
To perform radiotherapy, refer to the center of Imam Reza Mashhad
Age is between 18 and 60 years old
Is alert
Stage cancer is zero, one, two or three, and non-metastatic.(Based on diagnostic tests, signs and clinical examinations and approval of an oncology specialist)
There is no peripheral vascular disease, such as peripheral vascular thrombosis, burger disease, diabetes, ulcers, infection or cancer and foot radiotherapy and peripheral sensory loss
Do not use hypnotic and sedative drugs
There is no history of hospitalization for psychiatric causes (Stress, anxiety, Depression)
The phone number has been provided to the researcher for follow up
At the same time, chemotherapy and other therapies, including hormone therapy,Target therapy, heat therapy, and cold therapy are not used
During the period of radiotherapy, Patient will stay at the Reza Health Center nursing home
In response to the Smith's Fatigue Questionnaire, patient earns a score of 30 and above
In response to the Pittsburgh Sleep Quality Questionnaire, patient earns a score of 5 and above
Exclusion criteria:
-
Age
-
From 18 years old to 60 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
60
Actual sample size reached:
62
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomization type: Simple
This method uses computer randomization methods and divides people into two groups randomly by sequences generated by spss software.
The method of concealing Allocation Concealment is done by the statistics consultant.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-05-28, 1398/03/07
-
Ethics committee reference number
-
IR.MUMS.NURSE.REC.1398.022
Health conditions studied
1
-
Description of health condition studied
-
Caner
-
ICD-10 code
-
C80
-
ICD-10 code description
-
Malignant neoplasm without specification of site
Primary outcomes
1
-
Description
-
Fatigue
-
Timepoint
-
At the beginning of the study (before the intervention) and 7, 14 and 28 days after the intervention began
-
Method of measurement
-
Smith's Fatigue Questionnaire
2
-
Description
-
Sleep Quality
-
Timepoint
-
At the beginning of the study (before the intervention) and 7, 14 and 28 days after the intervention began
-
Method of measurement
-
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
1
-
Description
-
depression
-
Timepoint
-
At the beginning of the study (before the intervention) and on the 28th day of the radiotherapy course
-
Method of measurement
-
Depression- Anxiety- Stress Scale (DASS-21)
2
-
Description
-
Anxiety
-
Timepoint
-
At the beginning of the study (before the intervention) and on the 28th day of the radiotherapy course
-
Method of measurement
-
Depression- Anxiety- Stress Scale (DASS-21)
3
-
Description
-
Stress
-
Timepoint
-
At the beginning of the study (before the intervention) and on the 28th day of the radiotherapy course
-
Method of measurement
-
Depression- Anxiety- Stress Scale (DASS-21)
4
-
Description
-
Quality of Life
-
Timepoint
-
At the beginning of the study (before the intervention) and on the 28th day of the radiotherapy course
-
Method of measurement
-
Quality of Life Questionnaire of European Organization for Research and Treatment of Cancer
Intervention groups
1
-
Description
-
Intervention group1 : In the group of floating legs in warm water, patients from the seventh day after starting radiotherapy every night for two weeks an hour before normal sleep hours (between 9 to 10 pm) float their legs 10 cm above the wrist in water (41 to 42 ° C) for 20 minutes Inside the plastic container with a size of 40 × 27 × 45
-
Category
-
Rehabilitation
2
-
Description
-
Intervention group2:Intervention is performed for two weeks from the seventh day after starting radiotherapy every night for 10 minutes with olive oil for each foot massage. Reflexology intervention includes preparation, warm-up and stimulation and massage techniques which is done at the point of the solar plexus at the end of the first metatarsal bone of the foot to reduce fatigue, and at the pituitary gland and pineal gland at the toe to improve sleep quality. Massage duration for each foot is 10 minutes.( 1 minute general foot massage and each area 3 minutes). The pressure is 4 to 5 kilogram, which the intervener calibrates by applying pressure on a digital scale to the amount of pressure on his hand. The patient should lie on the bed in a supine position so that the floor of both feet is at the end of the bed and is fully exposed and the intervener sits on a chair at the end of the bed so that the patient's foot is in front of her and in complete control.
-
Category
-
Rehabilitation
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Mashhad 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Yes - There is a plan to make this available
-
Data Dictionary
-
Yes - There is a plan to make this available
-
Title and more details about the data/document
-
Presentation of research findings in seminars, conferences and publishing articles extracted from research, in magazines at home and abroad for use by cancer patients as well as researchers who intend to conduct research on the subject.
-
When the data will become available and for how long
-
Start of access period 6 months after printing results
-
To whom data/document is available
-
Share the results of the research with other researchers for further research.
-
Under which criteria data/document could be used
-
The results obtained in this study can be used in the oncology wards of all hospitals and even in other wards, especially in chronic patients who require specific medications following the consequences of their long-term treatment and intensive care.
-
From where data/document is obtainable
-
Mashhad School of Nursing and Midwifery
-
What processes are involved for a request to access data/document
-
After the email is sent to the scientifically responsible person, the accountability process begins.
-
Comments
-