To determine the effect of Foot reflexology on pain, fatigue, and sleep quality of patients undergoing renal transplantation surgery
Design
A randomized, parallel group clinical trial with a control group and without blinding
Settings and conduct
The study will be conducted on all patients with a kidney transplant in Afzalipour Hospital. The intervention will be done as a 30-minute massaging in three sessions. The pain, fatigue and sleep quality of patients will be measured before the intervention, immediately after the intervention and one week after the intervention
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients undergoing renal transplantation surgery, Being at least 15 years old, Having kidney transplant for the first time, Having no problems in feet, especially the sole;
Exclusion Criteria: Having the experience of using foot reflexology
Intervention groups
Intervention group: In 3 sessions, the massaging protocol will be performed for 30 minutes on both feet, in 3 consecutive days.
Control group: In the control group, no action will be taken.
Main outcome variables
Pain; Fatigue; Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170116031972N6
Registration date:2018-08-03, 1397/05/12
Registration timing:registered_while_recruiting
Last update:2018-08-03, 1397/05/12
Update count:0
Registration date
2018-08-03, 1397/05/12
Registrant information
Name
Mahlagha Dehghan Anari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5201
Email address
m_dehghan@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Foot reflexology on pain, fatigue, and sleep quality of patients undergoing renal transplantation surgery
Public title
The effect of foot reflexology on patients undergoing renal transplantation surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being at least 15 years old
Having kidney transplant for the first time
Having no problems in feet, especially the sole
Having full vigilance after the surgery
No drug or alcohol addiction
Patients undergoing renal transplantation surgery
Exclusion criteria:
Being blind or deaf
Having the experience of using foot reflexology
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into the intervention and control group using the method of Minimization. Samples will be allocated to two groups according to gender variable and age (±2). In other words, the first sample is randomly assigned (using coin flipping or heads or tails) to one of the intervention or control groups, and the subsequent sample is allocated to the other group according to the matching variables (gender and age (±2)). If the subsequent sample would not match with the previous sample, it will be randomly assigned (using coin flipping or heads or tails) to one of the intervention or control groups using coin flipping or heads or tails. This process will continue until the sampling end so that at the end of the sampling, the two groups will be similar in age (±2) and gender.
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 Kerman University of Medical Sciences
Street address
Ebnesina St, Jahad Blvd, Somaye Crossroad, Kerman
City
Kerman
Province
Kerman
Postal code
7815789957
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.KMU.REC.1397.071
Health conditions studied
1
Description of health condition studied
Patients' pain after renal transplantation surgery
ICD-10 code
R52.0
ICD-10 code description
Acute pain
2
Description of health condition studied
Patients' fatigue after renal transplantation surgery
ICD-10 code
R53
ICD-10 code description
Malaise and fatigue
3
Description of health condition studied
Patients' sleep quality after renal transplantation surgery
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
4
Description of health condition studied
Kidney transplant
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
Patient's pain score in Visual Analog Scale (VAS)
Timepoint
The first day after surgery, the second day after surgery before the intervention, immediately after the final session of intervention and one week after the final session of intervention
Method of measurement
Visual Analog Scale (VAS)
2
Description
Patient's fatigue score in Visual Analog Scale (VAS)
Timepoint
The first day after surgery, the second day after surgery before the intervention, immediately after the final session of intervention and one week after the final session of intervention
Method of measurement
Visual Analog Scale (VAS)
3
Description
Patient's sleep quality score in Pittsburgh Sleep Quality Index (PSQI)
Timepoint
The first day after surgery, the second day after surgery before the intervention, immediately after the final session of intervention and one week after the final session of intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Massaging intervention starts from the second day after the surgery. The massaging session starts in the final hours of the evening shift, at least 4 hours after the last time the sample received the last sedative. First, a quiet and bright environment will be prepared for the sample. Then massaging starts, first, the sole of the foot is gently massaged, gentle massage takes place in 3 minutes of the beginning and the final minutes of the intervention. The researcher takes the heel of one of the feet in his/her left hand and with the right-hand thumb applies pressure on the corresponding reflex points. The researcher, with his palm, pulls and pushes the outer edge of the foot forward and backward. For those samples who rarely go to the relaxation state, the solar plexus in the sole of the foot is also massaged to make the sample relax. Also, the parts related to the pineal gland are massaged in the outer part of the toe with slow speed and with regular rhythm or depth that is tolerable to the sample. The protocol is performed for 30 minutes on both feet (15 minutes each) for 3 sessions in 3 consecutive days.
Category
Rehabilitation
2
Description
Control group: In the control group, the researcher will do nothing and nurses will do caring procedures according to the protocol of the ward.