NCT05882227

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 23, 2023

Last Update Submit

May 21, 2023

Conditions

OsteoarthrosisERASAnxietyNurse

Keywords

hip arthroplastyERASNursing care

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (1)

  • Sociodemographic variables

    These variables will be collected 24 hours after surgery just prior to discharge from the hospital.

Study Arms (2)

Video

EXPERIMENTAL

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

Traditional information

ACTIVE COMPARATOR

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

Interventions

videoBEHAVIORAL

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.

Video
Traditional informationBEHAVIORAL

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.

Traditional information

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elisabet Ripoll Romero

Barcelona, 08004, Spain

RECRUITING

Related Publications (4)

  • Montin L, Suominen T, LeiniKilpi H. The experiences of patients undergoing total hip replacement. Journal of Orthopaedic Nursing. 2002 febrer; 6(1): 23-29.

    BACKGROUND

  • Montin L, Suominen T, Leino-Kilpi H.The experiences of patients undergoing total hip replacement. Journal of Orthopaedic Nursing.2002;6(1):23-29.

    BACKGROUND

  • his document should be cited as: EuroQol Research Foundation. EQ-5D-3L User Guide, 2018. Available from: https://euroqol.org/publications/user-guides.

    BACKGROUND

  • 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.

    PMID: 25005549BACKGROUND

MeSH Terms

Conditions

OsteoarthritisAnxiety Disorders

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Zaida Agüera, Nurse

    barcelona University

    STUDY DIRECTOR

Central Study Contacts

Elisabet Ripoll, Nurse

CONTACT

+34651786111eripoll@clinic.cat

Jordi Galimany, Nurse

CONTACT

+34651786111jordigalimany@ub.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 23, 2023

First Posted

May 31, 2023

Study Start

June 20, 2023

Primary Completion

December 20, 2023

Study Completion

May 20, 2024

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)