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Completed

NCT Number: NCT02287571

Skin Traction Versus Position Splint in Patients With Hip Fracture

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.

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Key information

Conditions

Hip Fractures Behavior Complication of Traction Procedure Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms Splints Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane Military Medical Academy

Ankara, 06018, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Derotation splint

Device

This group is the actual intervention group.

elastic bandage

Device

This group is the routine treatment (control) valid in the clinical practice.

Primary outcomes

  1. Pain

    Time frame: up to 7 days

    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.

  2. Comfort

    Time frame: up to 7 days

    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.

  3. Satisfaction from the treatment

    Time frame: Up to 7 days

    Satisfaction from the treatment was assessed by VAS score from the next day after intervention till the surgery.

Secondary outcomes

  1. Complications

    Time frame: Up to 7 days

    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.

  2. Surgery duration

    Time frame: participants were followed for the duration of surgical procedure, an average of 2 hours

    Time that the surgical procedure has taken was assessed.

  3. Hospitalization duration

    Time frame: participants were followed for the duration of hospital stay, an average of 2 weeks

    Time spent in the hospital till discharge was assessed.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 10, 2014
Registry last updated
Nov 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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