Clinical trial NCT05882227: Nursing Intervention for the Reduction of Anxiety During the Process of Primary Total Hip Arthroplasty Within the Optimized Recovery Program.
Official title: Nursing Intervention for the Reduction of Anxiety During the Process of Primary Total Hip Arthroplasty Within the Optimized Recovery Program.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthrosis
ERAS
Anxiety
Nurse
Keywords: hip arthroplasty
ERAS
Nursing care
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Osteoarthrosis (OA) is a chronic, degenerative disease characterized by joint wear and tear. It is a major cause of pain, disability and decreased quality of life. Total hip arthroplasty (THA) and total knee arthroplasty (TKA) represent an effective alternative for the treatment and pain control of patients with osteoarthritis. The "fast-track" program is translated as enhanced recovery or fast-track, and consists of the active participation of patients in their own recovery and immediate post-surgical mobilization, thanks to preoperative education through an educational workshop, the type of analgesia used and the empowerment of the patient in his or her own recovery.

The problem of anxiety in the surgical patient and the role of nurses in it has been widely studied for some decades, as shown in the scientific literature. Our experience as professionals of a hospital unit of orthopedic surgery and traumatology shows us the reality of this situation and the investigators find that when discharging patients who have undergone surgery and are discharged after 24 hours, the patient almost globally manifests a series of expressions, behaviors or behaviors that are related to anxious behavior, a completely natural human response of a patient who does not know what he is going to face. This leads us to detect a need to reinforce the information provided at discharge and the accompaniment during the first weeks after discharge.

Anxiety is a complex reaction to potentially dangerous situations or stimuli. It is an alarm signal that triggers a series of responses to cope with the situation. Anxiety is an emotional response that encompasses unpleasant cognitive aspects and physiological alterations that manifest themselves with high nervousness and even motor alterations.

Surgery is perceived by the patient as an important stress factor that can translate into nervousness and anxiety. Anxiety is almost always present during surgery, to a greater or lesser degree, both preoperatively and postoperatively.

Several studies have shown that good preoperative information reduces preoperative and postoperative anxiety. Patients need information about their process since dispelling their doubts will minimize anxiety. Currently there is very little information on anxiety during the whole surgical process. Therefore, in the present project the investigators propose to carry out a research study to analyze whether nursing intervention has beneficial results in the surgical patient.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled with signed consent for primary hip arthroplasty surgery, age over 18 years, patients who agree to participate in the study.

Exclusion Criteria:

* Patients who are discharged to a social-health center, patients with cognitive or mental disorders, patients who cannot read or write.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Before the surgical intervention during the visit with the advanced practice nurse (APN) who will measure the pre-intervention outcome.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 24 hours after surgery just prior to discharge from the hospital.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: One month after surgery when patiente comes to visit the doctor.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: six months after surgery when patiente comes to visit the doctor.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: A year after surgery just prior to discharge from the hospital.
measure: EuroQol-5D
timeFrame: Before the surgical intervention during the visit with the advanced practice nurse (APN) who will measure the pre-intervention outcome.
measure: EuroQol-5D
timeFrame: 24 hours after surgery just prior to discharge from the hospital.
measure: EuroQol-5D
timeFrame: One month after surgery when patiente comes to visit the doctor.
measure: EuroQol-5D
timeFrame: six months after surgery when patiente comes to visit the doctor.
measure: EuroQol-5D
timeFrame: a year after surgery when patiente comes to visit the doctor.
Secondary outcomes:
measure: Sociodemographic variables
timeFrame: These variables will be collected 24 hours after surgery just prior to discharge from the hospital.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Elisabet Ripoll Romero
Study officials:
affiliation: barcelona University
name: Zaida Agüera, Nurse
role: STUDY_DIRECTOR
References:
citation: Montin L, Suominen T, LeiniKilpi H. The experiences of patients undergoing total hip replacement. Journal of Orthopaedic Nursing. 2002 febrer; 6(1): 23-29.
citation: Montin L, Suominen T, Leino-Kilpi H.The experiences of patients undergoing total hip replacement. Journal of Orthopaedic Nursing.2002;6(1):23-29.
citation: his document should be cited as: EuroQol Research Foundation. EQ-5D-3L User Guide, 2018. Available from: https://euroqol.org/publications/user-guides.
citation: Stern AF. The hospital anxiety and depression scale. Occup Med (Lond). 2014 Jul;64(5):393-4. doi: 10.1093/occmed/kqu024. No abstract available.