Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02287571
Other study ID # B.10.4.ISM.4.06.68.49/
Secondary ID
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


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 allClick 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care