This study is going to be administered with the aim of determining the effect of foot reflexology massage on pain and anxiety of male patients after abdominal surgery in selected instructive hospitals of Tehran. The study will be quasi-experimental before and after which will be contain three groups of control, placebo, and intervention. The study population will consist of male patients who had an abdominal surgery. A sample size of 30 patients will be considered for each of the three groups. Sampling will initially based on objective and After selecting participants based on inclusion criteria, they randomly will be assigned to three groups: control, placebo, and intervention. Inclusion criteria: age between 15 to 60 years old; lack of analgesics before intervention; full consciousness after surgery; getting the minimum score of pain intensity from three and more base on the visual analogue scale; Lack of the experience of using foot reflexology massage; and exclusion criteria: lack of desire to continue cooperation in the study; tenderness or massage; and spinal anesthesia. The intervention will be done by the researcher in one session without using cream or conditioner for 30 minutes (each leg 15 minutes) for certain areas in all regions of the foot and abdominal surgery due to surgical site to reduce pain and anxiety in the leg and Immediately after the massage, 10 minutes, and 24 hours after the end of the massage, the pain and anxiety of patient would be measured and recorded.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016053128200N1
Registration date:2016-07-04, 1395/04/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-04, 1395/04/14
Registrant information
Name
Abolfazl Rahimi Zarchi
Name of organization / entity
Tehran University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0085
Email address
ab.rahimi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology massage on pain and anxiety of male patients after abdominal surgery
Public title
The effect of foot reflexology massage on pain and anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: admitted for abdominal surgery; Age between 15 to 60 years old; lack of analgesics before intervention having; healthy feet, especially the soles of them; getting the minimum score of pain intensity from three and more base on the visual analogue scale; full consciousness after surgery; Lack of addiction to drugs, alcohol and...; Lack of sensory and motor derangement according to the doctor's opinion or the existent information in the document or the patient saying itself; Lack of fever and skin diseases according to the doctor's opinion or the existent information in the document or the patient saying itself; Lack of hearing disorders according to the doctor's opinion or the existent information in the document or the patient saying itself; Lack of any physical and mental disorder except recent surgery according to the doctor's opinion or the existent information in the document or the patient saying itself; Lack of the experience of using foot reflexology massage; Lack of Chronic pain in other parts of the body (migraine, low back pain and ...) according to the doctor's opinion or the existent information in the document or the patient saying itself; Exclusion criteria: addiction diagnostic to drugs, alcohol, etc. After the inclusion; spinal anesthesia; lack of desire to continue cooperation in the study; tenderness or massage; any intervention process because the person is unable to tolerate or pursue
Age
From 15 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Simple random
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Avenue, Daneshjo Blvd., Evin, Tehran
City
Tehran
Postal code
1985713834
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.USWR.REC.1394.31
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R10.0
ICD-10 code description
Acute abdomen
2
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
pain
Timepoint
immediately before intervention- immediately after invention- 10 minutes after intervention- 24 hours after intervention
Method of measurement
visual analog scale
2
Description
anxiety
Timepoint
immediately before intervention- immediately after invention- 10 minutes after intervention- 24 hours after intervention
Method of measurement
Spielberger anxiety inventory
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: to relieve the pain of experimental group, foot reflexology massage is used and narcotic drugs as well if necessary. The intervention of experimental group includes foot reflexology massage which is done by the researcher after training and receiving the certification of reflexology performance from massage Art Institute of Iran. Foot reflexology massage is done without using cream or conditioner for 30 minutes (15 minutes per foot) in certain areas of abdominal surgery on foot. Then immediately after intervention, ten minutes later, and 24 hours later the intervention, the severity of pain and anxiety is measured.
Category
Placebo
2
Description
Control group: for control group, analgesic drugs in necessary situations and usual care are done. There is no intervention in control group, but just in time parallel with the experimental group, its severity of pain and anxiety is measured.
Category
Placebo
3
Description
Placebo group: for the placebo group, a simple massage on the foot is done and analgesic drugs as well if necessary. The severity of pain and anxiety of patients is measured immediately before the intervention. Then a 30 minute massage movements not the real massage runs in the sole of the patient's foot. These pressures are not on the surgical parts of the patient, then immediately, ten minutes and 24 hours after the end of the massage, the intensity of pain and anxiety is measured.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Ms. Jafary- Bachelor of Nursing
Street address
Imam Khomeini Hospital Complex, The western end of Keshavarz Boulevard, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Doctor Mohammad Ali Hosseini
Street address
Kodakyar Avenue, Daneshjo Blvd., Evin, Tehran
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran University of Social Welfare and Rehabilitation 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
Tehran University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Abolfazl Rahimi Zarchi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Kodakyar Avenue, Daneshjo Blvd., Evin, Tehran
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0085
Fax
+98 22180109
Email
amozesh@uswr.ac.ir
Web page address
http://www.uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Doctor Mohammad Ali Hosseini
Position
Associate Professor- Postdoctoral knowledge transfer from the University of Technology Sydney, Austr
Other areas of specialty/work
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0085
Fax
+98 22180109
Email
amozesh@uswr.ac.ir
Web page address
http://www.uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Abolfazl Rahimi Zarchi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0085
Fax
+98 22180109
Email
amozesh@uswr.ac.ir
Web page address
www.uswr.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)