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Skin Traction Versus Position Splint in Patients With Hip Fracture

Primary Purpose

Hip Fractures, Complication of Traction Procedure, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Derotation splint
elastic bandage
Sponsored by
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Fractures focused on measuring comfort, satisfaction

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being inpatient who were planned the surgery due to the hip fracture (caput femur fracture, collum femur fracture, femur intertrochanteric fracture and subtrochanteric fracture) diagnosis in the Orthopedics and Traumatology Clinic
  • Being 50 years old or more
  • Patients who speak and literate in Turkish
  • Patients who gave informed consent to participate in the study

Exclusion Criteria:

  • Any condition that emerges an obstacle for verbal and written interaction during data collection phase
  • Unable to perform written or verbal communication in Turkish
  • Withdrawal from the study due to medical reasons or death, at his/her will prior to preoperative data collection
  • Urgent non-elective surgery
  • Physician decision that do accept the method of immobilization assigned to the patient as appropriate

Sites / Locations

  • Gulhane Military Medical Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Skin traction

Position splint

Arm Description

Prior to hip fracture surgery, affected limb was wrapped with a special elastic bandage and pulled from the sole of the foot with a weight of 5-10% of total body weight of the patient (min 2.3 kg, max 4.5 kg).

Prior to hip fracture surgery, position splint was applied to the affected limb in order to keep the extremity in the proper positon without any weight lifting.

Outcomes

Primary Outcome Measures

Pain
Pain was assessed by VAS score prior to intervention, 15, 30, 60 and 120 minutes after intervention and daily from the next morning of intervention till the surgery.
Comfort
Comfort was assessed by VAS score prior to intervention, 15, 30, 60 and 120 minutes after intervention and by Immobilization Comfort Questionnaire daily from the next morning of intervention till the surgery.
Satisfaction from the treatment
Satisfaction from the treatment was assessed by VAS score from the next day after intervention till the surgery.

Secondary Outcome Measures

Complications
Complications (pressure ulcer, deep vein thrombosis, allergic skin reaction, pulmonary and urinary tract infection and constipation due to immobilization) were evaluated daily after intervention till the surgery.
Surgery duration
Time that the surgical procedure has taken was assessed.
Hospitalization duration
Time spent in the hospital till discharge was assessed.

Full Information

First Posted
November 3, 2014
Last Updated
November 6, 2014
Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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1. Study Identification

Unique Protocol Identification Number
NCT02287571
Brief Title
Skin Traction Versus Position Splint in Patients With Hip Fracture
Official Title
The Effects of Preoperative Skin Traction and Position Splint on Pain, Comfort and Satisfaction in Patients With Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this prospective, randomized controlled trial is to compare the effects of preoperative skin traction and position splint on pain, comfort, complications, difficulty level of nursing interventions, satisfaction from treatment and nursing care in patients with hip fracture. The sample is comprised of 34 patients with hip fracture in each group, totally 68 patients. Skin traction and position splint were applied after block randomization. Data regarding pain, comfort, satisfaction from care, immobilization comfort, complications, time of operation and hospitalization time were collected after intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Complication of Traction Procedure, Pain, Splints
Keywords
comfort, satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skin traction
Arm Type
Active Comparator
Arm Description
Prior to hip fracture surgery, affected limb was wrapped with a special elastic bandage and pulled from the sole of the foot with a weight of 5-10% of total body weight of the patient (min 2.3 kg, max 4.5 kg).
Arm Title
Position splint
Arm Type
Experimental
Arm Description
Prior to hip fracture surgery, position splint was applied to the affected limb in order to keep the extremity in the proper positon without any weight lifting.
Intervention Type
Device
Intervention Name(s)
Derotation splint
Intervention Description
This group is the actual intervention group.
Intervention Type
Device
Intervention Name(s)
elastic bandage
Intervention Description
This group is the routine treatment (control) valid in the clinical practice.
Primary Outcome Measure Information:
Title
Pain
Description
Pain was assessed by VAS score prior to intervention, 15, 30, 60 and 120 minutes after intervention and daily from the next morning of intervention till the surgery.
Time Frame
up to 7 days
Title
Comfort
Description
Comfort was assessed by VAS score prior to intervention, 15, 30, 60 and 120 minutes after intervention and by Immobilization Comfort Questionnaire daily from the next morning of intervention till the surgery.
Time Frame
up to 7 days
Title
Satisfaction from the treatment
Description
Satisfaction from the treatment was assessed by VAS score from the next day after intervention till the surgery.
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
Complications
Description
Complications (pressure ulcer, deep vein thrombosis, allergic skin reaction, pulmonary and urinary tract infection and constipation due to immobilization) were evaluated daily after intervention till the surgery.
Time Frame
Up to 7 days
Title
Surgery duration
Description
Time that the surgical procedure has taken was assessed.
Time Frame
participants were followed for the duration of surgical procedure, an average of 2 hours
Title
Hospitalization duration
Description
Time spent in the hospital till discharge was assessed.
Time Frame
participants were followed for the duration of hospital stay, an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being inpatient who were planned the surgery due to the hip fracture (caput femur fracture, collum femur fracture, femur intertrochanteric fracture and subtrochanteric fracture) diagnosis in the Orthopedics and Traumatology Clinic Being 50 years old or more Patients who speak and literate in Turkish Patients who gave informed consent to participate in the study Exclusion Criteria: Any condition that emerges an obstacle for verbal and written interaction during data collection phase Unable to perform written or verbal communication in Turkish Withdrawal from the study due to medical reasons or death, at his/her will prior to preoperative data collection Urgent non-elective surgery Physician decision that do accept the method of immobilization assigned to the patient as appropriate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betul Tosun, RN, PhD
Organizational Affiliation
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ozlem Aslan, Assoc.Prof.
Organizational Affiliation
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Official's Role
Study Chair
Facility Information:
Facility Name
Gulhane Military Medical Academy
City
Ankara
ZIP/Postal Code
06018
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
16278188
Citation
Resch S, Bjarnetoft B, Thorngren KG. Preoperative skin traction or pillow nursing in hip fractures: a prospective, randomized study in 123 patients. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1191-5. doi: 10.1080/09638280500055800.
Results Reference
background
PubMed Identifier
20345356
Citation
Saygi B, Ozkan K, Eceviz E, Tetik C, Sen C. Skin traction and placebo effect in the preoperative pain control of patients with collum and intertrochanteric femur fractures. Bull NYU Hosp Jt Dis. 2010;68(1):15-7.
Results Reference
background
PubMed Identifier
23187429
Citation
Endo J, Yamaguchi S, Saito M, Itabashi T, Kita K, Koizumi W, Kawaguchi Y, Asaka T, Saegusa O. Efficacy of preoperative skin traction for hip fractures: a single-institution prospective randomized controlled trial of skin traction versus no traction. J Orthop Sci. 2013 Mar;18(2):250-5. doi: 10.1007/s00776-012-0338-1. Epub 2012 Nov 28.
Results Reference
background
PubMed Identifier
11232658
Citation
Rosen JE, Chen FS, Hiebert R, Koval KJ. Efficacy of preoperative skin traction in hip fracture patients: a prospective, randomized study. J Orthop Trauma. 2001 Feb;15(2):81-5. doi: 10.1097/00005131-200102000-00001.
Results Reference
background
PubMed Identifier
16278174
Citation
Koval KJ, Cooley MR. Clinical pathway after hip fracture. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1053-60. doi: 10.1080/09638280500056618.
Results Reference
background
PubMed Identifier
24521802
Citation
Hili S, Dawe EJ, Lindisfarne EA, Stott PM. Perioperative management of elderly patients suffering a hip fracture. Br J Hosp Med (Lond). 2014 Feb;75(2):78-82. doi: 10.12968/hmed.2014.75.2.78.
Results Reference
background
PubMed Identifier
12466869
Citation
Yip DK, Chan CF, Chiu PK, Wong JW, Kong JK. Why are we still using pre-operative skin traction for hip fractures? Int Orthop. 2002;26(6):361-4. doi: 10.1007/s00264-002-0387-8. Epub 2002 Jul 13.
Results Reference
background
PubMed Identifier
8376442
Citation
Anderson GH, Harper WM, Connolly CD, Badham J, Goodrich N, Gregg PJ. Preoperative skin traction for fractures of the proximal femur. A randomised prospective trial. J Bone Joint Surg Br. 1993 Sep;75(5):794-6. doi: 10.1302/0301-620X.75B5.8376442.
Results Reference
background
PubMed Identifier
22161361
Citation
Handoll HH, Queally JM, Parker MJ. Pre-operative traction for hip fractures in adults. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD000168. doi: 10.1002/14651858.CD000168.pub3.
Results Reference
background
PubMed Identifier
9828472
Citation
Levi N. Is preoperative tibial traction responsible for peroneal nerve palsy in patients with a fractured hip? Acta Orthop Belg. 1998 Sep;64(3):273-6.
Results Reference
background
PubMed Identifier
1618564
Citation
Finsen V, Borset M, Buvik GE, Hauke I. Preoperative traction in patients with hip fractures. Injury. 1992;23(4):242-4. doi: 10.1016/s0020-1383(05)80007-5.
Results Reference
background
Links:
URL
http://www.thecomfortline.com/
Description
immobilization comfort questionnaire that was used to evaluate the late period comfort of hip fracture patients is based on the comfort theory which was developed by Kathy Kolcaba.

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Skin Traction Versus Position Splint in Patients With Hip Fracture

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