Cairo University Hospitals
Giza, Giza Governorate, 2356, Egypt
Location status: Recruiting
NCT Number: NCT07427758
The goal of this clinical trial study is to evaluate the effectiveness of cognitive behavioral therapy in reducing kinesiophobia and improving Clinical outcomes in postoperative patients following total hip arthroplasty The main question it aims to answer is:
Does the addition of cognitive behavioral therapy to standard physical therapy rehabilitation exercise reduce kinesiophobia and pain while improving functional mobility and quality of life in postoperative patients after total hip arthroplasty ? Participants will be divided into two groups to be compared: the first group (Control group) will only receive standard physical therapy rehabilitation exercises , consistent with routine post-total hip arthroplasty care, while the second group ( experimental group) will receive the same program in addition to cognitive behavioral therapy.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Giza, Giza Governorate, 2356, Egypt
Location status: Recruiting
Cognitive behavioral therapy is a psychological therapy that helps individuals modify unhelpful thoughts and behaviors to improve emotions and functioning (American Psychological Association , 2017). Emerging studies have shown that cognitive behavioral therapy is effective in reducing kinesiophobia in postoperative patients after joint athroplasty , with recent evidence specifically in total knee arthroplasty (Sun Et al.,2020).
Thus ,the investigators hypothesize that adding cognitive behavioral therapy (CBT) to a standard physical therapy rehabilitation program will improve kinesiophobia and clinical outcomes after total hip arthroplasty.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
((1) postoperative unilateral THA for the first time; (2) at least primary education; (3) ≥18 years of age ; (4) voluntary participation and close cooperation with the care plan; and (5) agreement to continue the intervention and the six-month follow-up after discharge,(6) high level of kinesiophobia on Tampa Scale of Kinesiophobia(TSK), (7)medically stable and cleared by their orthopedic surgeon.
Exclusion criteria
(1) revision surgery, (2) severe osteoarthritis in the contralateral hip, (3) severe acute metabolic neuromuscular and cardiovascular disease, (4) body mass index above 40, (5) presence of malignancy, any other orthopedic or neurologic problem that might affect treatment and assessments, (6) any condition that might interfere with communication, (7) or lack of cooperation during the study.(9) Individuals with cognitive disorder,(10) individuals with any psychological disease or disorder,(10) Had previously participated in a CBT intervention,(11) pregnancy.
Four Cognitive Behavioral Therapy sessions will be delivered over a 12-week period.
The Standard rehabilitation program consisting of active exercises will be delivered over a 12-week period
Time frame: Day 1 , 6 weeks , 12 weeks, 6 months as follow up.
To assess kinesiophobia ( fear of movement/re-injury) before and after intervention ( at four time points ).This scale uses individual item scores ranging from 1 to 4, where 1 indicates strong disagreement and 4 indicates strong agreement. Four negatively worded items (4, 8, 12, 16) are reverse-scored (4 = 1, 3 = 2, 2 = 3, 1 = 4). The total score ranges from 17 to 68, with higher scores indicating greater kinesiophobia. Scores above 37 are generally considered indicative of clinically relevant kinesiophobia
Time frame: day 1 , 6 weeks , 12 weeks, 6 months as follow up
To evaluate the effect of Cognitive Behavioral Therapy on pain perception. Scores range from 0 ( no pain) to 10 (worst pain)
Time frame: day 1 , 6weeks , 12 weeks , 6 months as follow up
To assess hip function, pain, and functional mobility on day 1 , 6weeks , 12 weeks , 6 months after surgery 90-100: excellent 80-89: good 70-79: fair <70: poor
Time frame: day 1, 6weeks , 12 weeks and 6 months as follow up.
To assess overall health-related quality of life on day 1, 6weeks , 12 weeks and 6 months after surgery. Scores range from 0 ( lowest score )-100 (highest score), with :
Higher scores: better health status and functioning Lower scores: worse health status and functioning
Contact information is provided by the study sponsor or research team.
Ahmad El Melhat, Phd
CONTACT
Sara Ahmad Manasfi, BSc
CONTACT
Cairo University
Other
Effect of Cognitive Behavioral Therapy on Kinesiophobia and Clinical Outcomes After Total Hip Arthroplasty: A Randomized Controlled Trial.
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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