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

Primary Purpose

Osteoarthrosis, ERAS, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
video
Traditional information
Sponsored by
University of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthrosis focused on measuring hip arthroplasty, ERAS, Nursing care

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Elisabet Ripoll RomeroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Video

Traditional information

Arm Description

patients will watch a video with discharge information taken from the document "Optimized hip replacement recovery program; information for patients, family members or caregivers".

patients will receive discharge information will be provided through the document entitled "Optimized Hip Replacement Recovery Program; Information for Patients, Family or Caregivers".

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Sociodemographic variables
Sex and age.

Full Information

First Posted
April 23, 2023
Last Updated
May 21, 2023
Sponsor
University of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05882227
Brief Title
Nursing Intervention for the Reduction of Anxiety During the Process of Primary Total Hip Arthroplasty Within the Optimized Recovery Program.
Acronym
NIRARATC
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Anticipated)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
May 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthrosis, ERAS, Anxiety, Nurse
Keywords
hip arthroplasty, ERAS, Nursing care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Video
Arm Type
Experimental
Arm Description
patients will watch a video with discharge information taken from the document "Optimized hip replacement recovery program; information for patients, family members or caregivers".
Arm Title
Traditional information
Arm Type
Active Comparator
Arm Description
patients will receive discharge information will be provided through the document entitled "Optimized Hip Replacement Recovery Program; Information for Patients, Family or Caregivers".
Intervention Type
Behavioral
Intervention Name(s)
video
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Traditional information
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Before the surgical intervention during the visit with the advanced practice nurse (APN) who will measure the pre-intervention outcome.
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
24 hours after surgery just prior to discharge from the hospital.
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
One month after surgery when patiente comes to visit the doctor.
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
six months after surgery when patiente comes to visit the doctor.
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
A year after surgery just prior to discharge from the hospital.
Title
EuroQol-5D
Description
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.
Time Frame
Before the surgical intervention during the visit with the advanced practice nurse (APN) who will measure the pre-intervention outcome.
Title
EuroQol-5D
Description
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.
Time Frame
24 hours after surgery just prior to discharge from the hospital.
Title
EuroQol-5D
Description
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.
Time Frame
One month after surgery when patiente comes to visit the doctor.
Title
EuroQol-5D
Description
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.
Time Frame
six months after surgery when patiente comes to visit the doctor.
Title
EuroQol-5D
Description
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.
Time Frame
a year after surgery when patiente comes to visit the doctor.
Secondary Outcome Measure Information:
Title
Sociodemographic variables
Description
Sex and age.
Time Frame
These variables will be collected 24 hours after surgery just prior to discharge from the hospital.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabet Ripoll, Nurse
Phone
+34651786111
Email
eripoll@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Jordi Galimany, Nurse
Phone
+34651786111
Email
jordigalimany@ub.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaida Agüera, Nurse
Organizational Affiliation
barcelona University
Official's Role
Study Director
Facility Information:
Facility Name
Elisabet Ripoll Romero
City
Barcelona
ZIP/Postal Code
08004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jordi Galimany, nurse
Phone
+34651786111
Email
jordigalimany@ub.edu
First Name & Middle Initial & Last Name & Degree
Zaida Agüera, nurse
Phone
+34651786111
Email
zaguera@ub.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
background
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.
Results Reference
background
Citation
his document should be cited as: EuroQol Research Foundation. EQ-5D-3L User Guide, 2018. Available from: https://euroqol.org/publications/user-guides.
Results Reference
background
PubMed Identifier
25005549
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.
Results Reference
background

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

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