The purpose of this study is to evaluate the effect of traction on preoperative pain in patients with hip fractures.
Design
A randomized, parallel, single-blind trial which is randomized with "random allocation" software. The sample size for each group with a confidence interval of 95% is 42.
Groups: One group will undergo skin traction until the surgery(Intervention group), and for the other group a pillow will be located under the affected lower limb (Control group).
Settings and conduct
The patients' treatment plans are written in sealed envelopes. No one is aware of the contents until it gets open in front of the patient. Based on the treatment plan each patient will be either in the intervention or in the control group.The severity of pain will be measured before and 2 hours after Traction application and every day until surgery using Visual Analogue Score(VAS). Opioid administration will also be documented as a confounding factor.
Participants/Inclusion and exclusion criteria
-Candidates for hip surgery due to low energy hip fractures admitted in the Kashani hospital.
-Signing the consent form.
Intervention groups
Intervention group: Patients for whom skin traction will be loaded and their pain will be measured until the operation.
Control group: Patients for whom skin traction will not be loaded and a pillow will be located under their knees and their pain will be measured until the operation.
Main outcome variables
Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180729040636N3
Registration date:2020-07-01, 1399/04/11
Registration timing:registered_while_recruiting
Last update:2020-07-01, 1399/04/11
Update count:0
Registration date
2020-07-01, 1399/04/11
Registrant information
Name
Hossein Akbari aghdam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2085
Email address
akbariaghdam@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-15, 1399/03/26
Expected recruitment end date
2020-07-16, 1399/04/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preoperative skin traction in pain control of patient with low energy fractures of hip
Public title
Skin traction's effect on the preoperative pain in hip fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for hip surgeries due to low energy hip fractures who admit Kashani hospital (Low-energy hip fractures)
Signing the consent form (Consent)
Exclusion criteria:
Concomitant fractures with the hip fracture (Concomitant fractures)
Neurological conditions of which the patient is unable to percept pain(Neurological issues)
Drug abuse in any sense (Addiction)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be done by the "random allocation" software. Each patient will be allocated as control or intervention based on this random allocation.
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 Isfahan University of Medical Sciences
Street address
Medical Isfahan university, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-06-01, 1399/03/12
Ethics committee reference number
IR.MUI.MED.REC.1399.189
Health conditions studied
1
Description of health condition studied
Low energy hip fractures
ICD-10 code
M84.359A
ICD-10 code description
Stress fracture, hip, unspecified, initial encounter for fracture
Primary outcomes
1
Description
Severity of the pain
Timepoint
before intervention, 2 hours after intervention, daily measure until the surgery
Method of measurement
A horizontal line with the length of 100 millimeter is shown to the patient. the line is divided into ten equal segments (each 10 millimeters) numbered 0 to 10(Visual Analogue Scale). The zero is named after no pain condition and 10 is introduced as the worst pain could exist. The patient is asked to mark the line based on his/her pain degree.