Clinical trial NCT02287571: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Complication of Traction Procedure
Pain
Splints
Keywords: comfort
satisfaction
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Pain
timeFrame: up to 7 days
measure: Comfort
timeFrame: up to 7 days
measure: Satisfaction from the treatment
timeFrame: Up to 7 days
Secondary outcomes:
measure: Complications
timeFrame: Up to 7 days
measure: Surgery duration
timeFrame: participants were followed for the duration of surgical procedure, an average of 2 hours
measure: Hospitalization duration
timeFrame: participants were followed for the duration of hospital stay, an average of 2 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Military Medical Academy
Study officials:
affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
name: Betul Tosun, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
name: Ozlem Aslan, Assoc.Prof.
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.