Comparison and determine the effect of progressive Muscle relaxation and foot reflexology on sleep quality in cancer patients undergoing chemotherapy
Design
The study is a single-blind randomized clinical trial. the sample size is 150 cancer patients.
Settings and conduct
Intervention is the study of sleep quality will conduct for 4 weeks onto cancer patients in Imam Reza hospital in Kermanshah-Iran.Patients will perform relaxation two time daily, each time 20 minutes and foot reflexology massage will be done for thirty minutes (every foot fifteen minutes) and the control group will receive routine care.
the Study is single-blinded.The data analyst will not be aware of the categorization of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Consent to participate in the study , Complete consciousness , score equal or more than five from the Pittsburgh quality of sleep questionnaire , ability of verbal communication, undergoing chemotherapy based on treatment protocols, lasting at least one month of chemotherapy history, doing at least two chemotherapy sessions, Not having skin wound,Infection and skin disease.
Exclusion criteria :
having coagulation disorder (due to the possibility of producing clots and thromboembolism), no tolerance of the massage, use of other complementary therapies for improving the sleep.
Intervention groups
Progressive muscle relaxation group:
Patients performed relaxation for 4 weeks, two time, daily, each time for 20 minutes, preferably once before bedtime.
Foot reflexology massage group:
Massage therapy is performed once a day, preferably before the patient's of sleeping for 4 weeks, each session of foot reflexology massage will last thirty minutes (every foot fifteen minutes) .
Control group: The control group will receive routine care.
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170619034641N4
Registration date:2018-07-27, 1397/05/05
Registration timing:registered_while_recruiting
Last update:2018-07-27, 1397/05/05
Update count:0
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Alireza Abdi
Name of organization / entity
nursing and midwifery school, Kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3725 0111
Email address
arabdi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect and Comparison of Progressive Muscle Relaxation and foot reflexology on sleep quality in cancer patients undergoing chemotherapy
Public title
The effect of muscle relaxation and foot reflexology massage on sleep of cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study.
Complete consciousness.
score equal or more than five from the Pittsburgh quality of sleep questionnaire
ability of verbal communication
undergoing chemotherapy based on treatment protocols.
lasting at least one month of chemotherapy history
doing at least two chemotherapy sessions.
Not having skin wound,Infection and skin disease.
Exclusion criteria:
Having coagulation disorder (due to the possibility of producing clots and thromboembolism).
No tolerance of the massage.
Use of other complementary therapies for improving the sleep
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 150 patients with inclusion criteria were randomly assigned into three groups in a randomized, randomized manner. for random allocation, we will chose three types of Cart with similar colors, and write the numbers of 1 to 3 upon them. one hundred and fifty carts will put inside a glass container the number 1 is related to progressive muscle relaxation group and card number 2 the reflexology massage group and card number 3 the control group. one cart will be allocated to any individual and he/she is placed in the relevant group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst does not know the categorization of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research, Kermanshah University of Medical Sciences, Shahid Beheshty Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
69531-13433
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.KUMS.REC.1397.135
Health conditions studied
1
Description of health condition studied
sleep quality
ICD-10 code
F51.8
ICD-10 code description
Other sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
sleep quality
Timepoint
At the beginning of the study and Four weeks after the intervention
Method of measurement
Pittsburgh sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention group: Progressive muscle relaxation:Patients perform practice relaxation for 4 weeks, two time, daily, each time lasts 20 minutes, preferably once will perform before bedtime.
Category
Rehabilitation
2
Description
Intervention group: Second intervention group: Foot reflexology massage: Massage is performed once a day, preferably before sleep for 4 weeks. each session lasts thirty minutes (each foot fifteen minutes). Five minutes of fifteen minutes is related to general foot massage on the soles of the foot and ten minutes of massage related to the Pineal gland point in the outer part of the foot thumb. Massage is done slowly, with regular rhythm and depth that is tolerable to the patient.
Category
Rehabilitation
3
Description
Control group: The control group will receive routine care.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospitals of Kermanshah
Full name of responsible person
Alireza AAbdi
Street address
Kermanshah University of Medical Sciences, Kermanshah, Shahid Beheshti Boulevard