Nursing Intervention for the Reduction of Anxiety During the Process of Primary Total Hip Arthroplasty Within the Optimized Recovery Program. (NIRARATC)

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Osteoarthrosis; Nurse; ERAS
• Intervention / Treatment: Behavioral: video; Behavioral: Traditional information

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabet Ripoll, Nurse; Phone Number: +34651786111; Email: eripoll@clinic.cat
• Study Contact Backup: Name: jordi Galimany, nurse; Phone Number: +34651786111; Email: jordigalimany@ub.edu

Study Locations

• Spain
  • Barcelona, Spain, 08004
    • Recruiting
    • Elisabet Ripoll Romero
    • Contact: jordi Galimany, nurse; Phone Number: +34651786111; Email: jordigalimany@ub.edu
    • Contact: Zaida Agüera, nurse; Phone Number: +34651786111; Email: zaguera@ub.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video; patients will watch a video with discharge information taken from the document "Optimized hip replacement recovery program; information for patients, family members or caregivers".	Behavioral: video; The patients will receive the discharge information through the visualization of a video with discharge information extracted from the optimized hip prosthesis recovery program document; information for patients, relatives or caregivers. The video will consist of two parts: a first part where it will be explained what will happen in the next hours in the unit, the documentation that will be delivered at discharge and the pharmacological treatment. The second part will consist of a video explaining wound care at discharge, discharge recommendations, symptoms that may appear after surgery and alarm symptoms.
Active Comparator: Traditional information; patients will receive discharge information will be provided through the document entitled "Optimized Hip Replacement Recovery Program; Information for Patients, Family or Caregivers".	Behavioral: Traditional information; Patients will receive the information at discharge by means of the document entitled "Optimized Hip Replacement Recovery Program; information for patients, relatives or caregivers", which will act as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale (HADS)	HADS is a self-report questionnaire designed to screen anxious and depressive states in patients in non-psychiatric settings. The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately.	Before the surgical intervention during the visit with the advanced practice nurse (APN) who will measure the pre-intervention outcome.
Hospital Anxiety and Depression Scale (HADS)	HADS is a self-report questionnaire designed to screen anxious and depressive states in patients in non-psychiatric settings. The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately.	24 hours after surgery just prior to discharge from the hospital.
Hospital Anxiety and Depression Scale (HADS)	HADS is a self-report questionnaire designed to screen anxious and depressive states in patients in non-psychiatric settings. The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately.	One month after surgery when patiente comes to visit the doctor.
Hospital Anxiety and Depression Scale (HADS)	HADS is a self-report questionnaire designed to screen anxious and depressive states in patients in non-psychiatric settings. The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately.	six months after surgery when patiente comes to visit the doctor.
Hospital Anxiety and Depression Scale (HADS)	HADS is a self-report questionnaire designed to screen anxious and depressive states in patients in non-psychiatric settings. The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately.	A year after surgery just prior to discharge from the hospital.
EuroQol-5D	The EQ-5D family of instruments have been developed to describe and value health across a wide range of disease areas. They are also frequently used in research into health in the general population. The EQ-5D-3L essentially consists of two pages: the EQ-5D descriptive system and the EQ-5D visual analogue scale.The EQ-5D-3L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems. The EQ VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.	Before the surgical intervention during the visit with the advanced practice nurse (APN) who will measure the pre-intervention outcome.
EuroQol-5D	The EQ-5D family of instruments have been developed to describe and value health across a wide range of disease areas. They are also frequently used in research into health in the general population. The EQ-5D-3L essentially consists of two pages: the EQ-5D descriptive system and the EQ-5D visual analogue scale.The EQ-5D-3L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems. The EQ VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.	24 hours after surgery just prior to discharge from the hospital.
EuroQol-5D	The EQ-5D family of instruments have been developed to describe and value health across a wide range of disease areas. They are also frequently used in research into health in the general population. The EQ-5D-3L essentially consists of two pages: the EQ-5D descriptive system and the EQ-5D visual analogue scale.The EQ-5D-3L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems. The EQ VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.	One month after surgery when patiente comes to visit the doctor.
EuroQol-5D	The EQ-5D family of instruments have been developed to describe and value health across a wide range of disease areas. They are also frequently used in research into health in the general population. The EQ-5D-3L essentially consists of two pages: the EQ-5D descriptive system and the EQ-5D visual analogue scale.The EQ-5D-3L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems. The EQ VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.	six months after surgery when patiente comes to visit the doctor.
EuroQol-5D	The EQ-5D family of instruments have been developed to describe and value health across a wide range of disease areas. They are also frequently used in research into health in the general population. The EQ-5D-3L essentially consists of two pages: the EQ-5D descriptive system and the EQ-5D visual analogue scale.The EQ-5D-3L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems. The EQ VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.	a year after surgery when patiente comes to visit the doctor.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic variables	Sex and age.	These variables will be collected 24 hours after surgery just prior to discharge from the hospital.

Collaborators and Investigators

• Sponsor: University of Barcelona
• Investigators: Study Director: Zaida Agüera, Nurse, Barcelona University

Publications and helpful links

General Publications

• 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.
• Montin L, Suominen T, LeiniKilpi H. The experiences of patients undergoing total hip replacement. Journal of Orthopaedic Nursing. 2002 febrer; 6(1): 23-29.
• Montin L, Suominen T, Leino-Kilpi H.The experiences of patients undergoing total hip replacement. Journal of Orthopaedic Nursing.2002;6(1):23-29.
• his document should be cited as: EuroQol Research Foundation. EQ-5D-3L User Guide, 2018. Available from: https://euroqol.org/publications/user-guides.

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2023
• Primary Completion (Estimated): December 20, 2023
• Study Completion (Estimated): May 20, 2024

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: May 21, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: ERAS; Nursing care; hip arthroplasty
• Additional Relevant MeSH Terms: Mental Disorders; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Anxiety Disorders
• Other Study ID Numbers: HCB/2023/0015; Jordi Galimany Masclans (Other Identifier: Barcelona University); Zaida Palmira Agüera Imbernón (Other Identifier: Barcelona University); Montserrat Puig Llobet (Other Identifier: Barcelona University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No