Skin Traction Versus Position Splint in Patients With Hip Fracture

Pain Clinical Trial

Official title:

The Effects of Preoperative Skin Traction and Position Splint on Pain, Comfort and Satisfaction in Patients With Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287571
• Other study ID #: B.10.4.ISM.4.06.68.49/
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: November 6, 2014
• Start date: March 2013
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Gulhane Military Medical Academy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Complication of Traction Procedure
• Fractures, Bone
• Hip Fractures
• Pain
• Splints

Intervention

Device:
• Derotation splint
This group is the actual intervention group.
• elastic bandage
This group is the routine treatment (control) valid in the clinical practice.

Locations

Country	Name	City	State
Turkey	Gulhane Military Medical Academy	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Military Medical Academy

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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. — View 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. — View Citation

Finsen V, Børset M, Buvik GE, Hauke I. Preoperative traction in patients with hip fractures. Injury. 1992;23(4):242-4. — View 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. Review. — View 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. Review. — View Citation

Koval KJ, Cooley MR. Clinical pathway after hip fracture. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1053-60. — View 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. — View Citation

Resch S, Bjärnetoft 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. — View 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. — View 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. — View 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. Epub 2002 Jul 13. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 7 days	No
Primary	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.	up to 7 days	No
Primary	Satisfaction from the treatment	Satisfaction from the treatment was assessed by VAS score from the next day after intervention till the surgery.	Up to 7 days	No
Secondary	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.	Up to 7 days	No
Secondary	Surgery duration	Time that the surgical procedure has taken was assessed.	participants were followed for the duration of surgical procedure, an average of 2 hours	No
Secondary	Hospitalization duration	Time spent in the hospital till discharge was assessed.	participants were followed for the duration of hospital stay, an average of 2 weeks	No

External Links

•   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.