Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647316
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Effects of an Early Physioterapy Program on the Emotional Well-being in Acute Hospitalized Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of a Physioterapy Program on the Emotional Well-being of Patiens Admitted to an Acute Hospitalization Unit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hospitalization due to acute illness often leads to a decline in physical function and quality of life which significantly impacts the emotional well-being of patients their families and primary caregivers Emotional well-being is a critical aspect of overall health enabling individuals to cope with and adapt to health challenges Addressing this dimension within the hospital setting is vital to improving patient outcomes particularly from a biopsychosocial perspective that considers physical psychological and social factors
This study aims to evaluate the effectiveness of physiotherapy interventions in enhancing the emotional well-being of hospitalized patients While early physiotherapy is well-documented for its benefits in preventing complications and improving physical recovery there is limited research demonstrating its impact on emotional well-being Furthermore data on the effects of prolonged hospitalization on the biopsychosocial health of patients is lacking
Conducted at the Hospital Universitario de la Princesa Madrid Spain a high-complexity hospital this project will assess the role of physiotherapy not only in physical recovery but also in fostering emotional support The intervention is designed to provide both therapeutic and emotional benefits incorporating moments of relaxation and leisure into the treatment sessions The study aligns with the growing global trend towards person-centered care and the humanization of healthcare
This approach emphasizes a more holistic and personalized patient experience where physiotherapy contributes to the overall health and well-being of the patient addressing their physical and emotional needs
This study aims to evaluate the effectiveness of physiotherapy interventions in enhancing the emotional well-being of hospitalized patients While early physiotherapy is well-documented for its benefits in preventing complications and improving physical recovery there is limited research demonstrating its impact on emotional well-being Furthermore data on the effects of prolonged hospitalization on the biopsychosocial health of patients is lacking
Conducted at the Hospital Universitario de la Princesa Madrid Spain a high-complexity hospital this project will assess the role of physiotherapy not only in physical recovery but also in fostering emotional support The intervention is designed to provide both therapeutic and emotional benefits incorporating moments of relaxation and leisure into the treatment sessions The study aligns with the growing global trend towards person-centered care and the humanization of healthcare
This approach emphasizes a more holistic and personalized patient experience where physiotherapy contributes to the overall health and well-being of the patient addressing their physical and emotional needs
Detailed Description:
Background
Hospitalization due to acute illness frequently results in a decline in physical function and quality of life significantly affecting the emotional well-being of patients their families and primary caregivers Emotional well-being is a crucial aspect of overall health enabling individuals to cope with and adapt to health challenges It is therefore essential that emotional well-being be addressed within the hospital setting if patient outcomes are to be improved particularly from a biopsychosocial perspective that considers physical psychological and social factors
The hypothesis is that the proposed intervention which focuses on patients admitted to the Hospital Universitario de la Princesa de la Comunidad de Madrid will effectively evaluate the role of hospital physiotherapy in improving emotional well-being
Although the advantages of early physiotherapy in preventing complications and enhancing physical recovery are well-documented there is a paucity of research demonstrating its impact on emotional well-being Furthermore there is a dearth of data concerning the effects of prolonged hospitalization on patients biopsychosocial health
The primary objective of this study is to assess the effectiveness of a physiotherapy intervention on the emotional well-being of patients admitted to the Hospital Universitario de La Princesa
Secondary objectives includes
Examining the impact of sociodemographic factors on the efficacy of physical therapy
Evaluating the influence of physical therapy on the quality of life of patients admitted to the hospital
Analyzing the needs of the primary caregiver of admitted patients It is hypothesized that physical therapy intervention in admitted patients at the Hospital Universitario de La Princesa improves their emotional well-being and quality of life
Sample Recruitment Participants will be recruited through the rehabilitation physician who also serves as the collaborating researcher and enrolls patients in the treatment program Patients can be referred by the different medical services of the Hospital Universitario de la Princesa Once a patient is enrolled in the study a member of the research team will inform them of the study and provide them with the appropriate patient information sheet and informed consent form
Study Design
This project uses a quasi-experimental analytic longitudinal prospective single-group study design to examine the effects of a physical therapy intervention on the emotional well-being of inpatients It employs a quasi-experimental design in which the investigator implements an intervention on a sample to examine the effects of physical therapy on emotional well-being and physical condition in real-world settings with a focus on quality of life This single-group pretest-posttest design involves assessing the same participants at two different points in time before the physical therapy intervention begins pretest and after it ends posttest
Therapeutic intervention The subjects will receive the first physiotherapy session in the unit where they are currently being treated The treatment will be adapted to the specific pathology of each patient according to medical guidelines
As a general intervention in immobilized patients early mobilization postural and joint ergonomics sensory stimulation temporal-spatial orientation and health education for the patient according to the level of cooperation and the main caregiver are carried out The intervention is always adapted to the initial situation pathology and needs
According to the patients progress the treatment plan is modified after review by the rehabilitation physician in accordance with established guidelines The plan will progress with postural control in a seated position head and trunk control re-education of transfers balance standing and walking depending on the subjects abilities
The second physical therapy session is also conducted at the patients location within the unit incorporating taste and preference-based elements into the therapy itself This may include the ability to select the music to be played during the session The individualized physiotherapy treatment is carried out according to the patients pathology and in accordance with established medical guidelines The goal is to promote the patients physical autonomy in accordance with the current initial situation using environmental indicators that facilitate the visualization of progress
The third physiotherapy session is planned to take place in the rehabilitation gym if the patients clinical condition allows it The same line of treatment will be continued and the humanizing approach developed on the ward will also be evident in the gym Following the individualized session group interaction is encouraged whether with other patients the rehabilitation team andor the patients primary caregiver
If physical therapy is provided on the ward it is also recommended that opportunities for group interaction with the professional team andor primary caregiver be encouraged
Group interaction will include the performance of activities in unison including active mobility exercises for the upper and lower extremities progressing to the administration of strengthening exercises for the primary muscle groups and the implementation of therapeutic measures through the use of virtual reality glasses The above-mentioned measures provide the patient with a calm close and more humane therapeutic environment
In the fourth physiotherapy session a personalized element is introduced in the form of consumable materials provided by the service with the aim of promoting therapeutic compliance and demonstrating the effort made by the patient
The above procedures will be continued in the physiotherapy sessions throughout the patients hospitalization
Group interaction will include the performance of activities in unison including active mobility exercises of the upper and lower extremities followed by progressive strengthening exercises of the primary muscle groups This will be done through the use of virtual reality goggles The aforementioned measures are designed to provide the patient with a calmer more intimate and more humane therapeutic environment
Once the patients clinical history is updated to indicate a probable discharge the initial scales will be administered once more to both the patient and the caregiver Furthermore the patient will be provided with a questionnaire for the purpose of assessing satisfaction with the treatment received
The physiotherapy intervention will comprise therapeutic exercises designed to facilitate physical recovery while also integrating moments of relaxation and leisure into treatment sessions This approach is aligned with the growing global trend toward person-centered care and the humanization of healthcare It emphasizes a holistic and personalized patient experience which is consistent with the principles of person-centered care and the humanization of healthcare
Outcomes
The primary outcome will be the assessment of emotional well-being which will be measured using validated scales at two time points before the intervention and after the intervention Secondary outcomes will include assessments of physical function quality of life and patient satisfaction with the quality of care received
Significance
The objective of this study is to address the existing gap in the literature regarding the effectiveness of physiotherapy interventions on emotional well-being By examining the impact of physiotherapy from a biopsychosocial perspective this research aims to provide insights into the ways in which prolonged hospitalization affects patients cognitive social and familial spheres Moreover it will highlight the necessity of integrating emotional support into physiotherapy practice
Clinical relevance
The role of the physiotherapist is evolving to encompass not only the physical aspects of rehabilitation but also the communication and emotional skills that facilitate optimal care The findings of this study will contribute to the existing body of knowledge regarding the ways in which physiotherapy can enhance both physical and emotional recovery thereby promoting a more comprehensive approach to patient care
Etical and Legal Considerations
This research project is conducted in accordance with all relevant ethical and legal regulations pertaining to research on human subjects
This project will be conducted in accordance with the fundamental principles of Good Clinical Practice as established in the Declaration of Helsinki and its subsequent modifications the latest of which was the Fortaleza 2013 World Medical Assembly as set forth in the Council of Europe Convention on Human Rights and Biomedicine and the UNESCO Universal Declaration on the Human Genome and Human Rights Furthermore the project will comply with the requirements set forth in the Spanish legislation pertaining to biomedical research specifically the Law 142007 of July 3 2007 on Biomedical Research and RD 17162011 on Biobanks as well as the regulations concerning the protection of personal data
Hospitalization due to acute illness frequently results in a decline in physical function and quality of life significantly affecting the emotional well-being of patients their families and primary caregivers Emotional well-being is a crucial aspect of overall health enabling individuals to cope with and adapt to health challenges It is therefore essential that emotional well-being be addressed within the hospital setting if patient outcomes are to be improved particularly from a biopsychosocial perspective that considers physical psychological and social factors
The hypothesis is that the proposed intervention which focuses on patients admitted to the Hospital Universitario de la Princesa de la Comunidad de Madrid will effectively evaluate the role of hospital physiotherapy in improving emotional well-being
Although the advantages of early physiotherapy in preventing complications and enhancing physical recovery are well-documented there is a paucity of research demonstrating its impact on emotional well-being Furthermore there is a dearth of data concerning the effects of prolonged hospitalization on patients biopsychosocial health
The primary objective of this study is to assess the effectiveness of a physiotherapy intervention on the emotional well-being of patients admitted to the Hospital Universitario de La Princesa
Secondary objectives includes
Examining the impact of sociodemographic factors on the efficacy of physical therapy
Evaluating the influence of physical therapy on the quality of life of patients admitted to the hospital
Analyzing the needs of the primary caregiver of admitted patients It is hypothesized that physical therapy intervention in admitted patients at the Hospital Universitario de La Princesa improves their emotional well-being and quality of life
Sample Recruitment Participants will be recruited through the rehabilitation physician who also serves as the collaborating researcher and enrolls patients in the treatment program Patients can be referred by the different medical services of the Hospital Universitario de la Princesa Once a patient is enrolled in the study a member of the research team will inform them of the study and provide them with the appropriate patient information sheet and informed consent form
Study Design
This project uses a quasi-experimental analytic longitudinal prospective single-group study design to examine the effects of a physical therapy intervention on the emotional well-being of inpatients It employs a quasi-experimental design in which the investigator implements an intervention on a sample to examine the effects of physical therapy on emotional well-being and physical condition in real-world settings with a focus on quality of life This single-group pretest-posttest design involves assessing the same participants at two different points in time before the physical therapy intervention begins pretest and after it ends posttest
Therapeutic intervention The subjects will receive the first physiotherapy session in the unit where they are currently being treated The treatment will be adapted to the specific pathology of each patient according to medical guidelines
As a general intervention in immobilized patients early mobilization postural and joint ergonomics sensory stimulation temporal-spatial orientation and health education for the patient according to the level of cooperation and the main caregiver are carried out The intervention is always adapted to the initial situation pathology and needs
According to the patients progress the treatment plan is modified after review by the rehabilitation physician in accordance with established guidelines The plan will progress with postural control in a seated position head and trunk control re-education of transfers balance standing and walking depending on the subjects abilities
The second physical therapy session is also conducted at the patients location within the unit incorporating taste and preference-based elements into the therapy itself This may include the ability to select the music to be played during the session The individualized physiotherapy treatment is carried out according to the patients pathology and in accordance with established medical guidelines The goal is to promote the patients physical autonomy in accordance with the current initial situation using environmental indicators that facilitate the visualization of progress
The third physiotherapy session is planned to take place in the rehabilitation gym if the patients clinical condition allows it The same line of treatment will be continued and the humanizing approach developed on the ward will also be evident in the gym Following the individualized session group interaction is encouraged whether with other patients the rehabilitation team andor the patients primary caregiver
If physical therapy is provided on the ward it is also recommended that opportunities for group interaction with the professional team andor primary caregiver be encouraged
Group interaction will include the performance of activities in unison including active mobility exercises for the upper and lower extremities progressing to the administration of strengthening exercises for the primary muscle groups and the implementation of therapeutic measures through the use of virtual reality glasses The above-mentioned measures provide the patient with a calm close and more humane therapeutic environment
In the fourth physiotherapy session a personalized element is introduced in the form of consumable materials provided by the service with the aim of promoting therapeutic compliance and demonstrating the effort made by the patient
The above procedures will be continued in the physiotherapy sessions throughout the patients hospitalization
Group interaction will include the performance of activities in unison including active mobility exercises of the upper and lower extremities followed by progressive strengthening exercises of the primary muscle groups This will be done through the use of virtual reality goggles The aforementioned measures are designed to provide the patient with a calmer more intimate and more humane therapeutic environment
Once the patients clinical history is updated to indicate a probable discharge the initial scales will be administered once more to both the patient and the caregiver Furthermore the patient will be provided with a questionnaire for the purpose of assessing satisfaction with the treatment received
The physiotherapy intervention will comprise therapeutic exercises designed to facilitate physical recovery while also integrating moments of relaxation and leisure into treatment sessions This approach is aligned with the growing global trend toward person-centered care and the humanization of healthcare It emphasizes a holistic and personalized patient experience which is consistent with the principles of person-centered care and the humanization of healthcare
Outcomes
The primary outcome will be the assessment of emotional well-being which will be measured using validated scales at two time points before the intervention and after the intervention Secondary outcomes will include assessments of physical function quality of life and patient satisfaction with the quality of care received
Significance
The objective of this study is to address the existing gap in the literature regarding the effectiveness of physiotherapy interventions on emotional well-being By examining the impact of physiotherapy from a biopsychosocial perspective this research aims to provide insights into the ways in which prolonged hospitalization affects patients cognitive social and familial spheres Moreover it will highlight the necessity of integrating emotional support into physiotherapy practice
Clinical relevance
The role of the physiotherapist is evolving to encompass not only the physical aspects of rehabilitation but also the communication and emotional skills that facilitate optimal care The findings of this study will contribute to the existing body of knowledge regarding the ways in which physiotherapy can enhance both physical and emotional recovery thereby promoting a more comprehensive approach to patient care
Etical and Legal Considerations
This research project is conducted in accordance with all relevant ethical and legal regulations pertaining to research on human subjects
This project will be conducted in accordance with the fundamental principles of Good Clinical Practice as established in the Declaration of Helsinki and its subsequent modifications the latest of which was the Fortaleza 2013 World Medical Assembly as set forth in the Council of Europe Convention on Human Rights and Biomedicine and the UNESCO Universal Declaration on the Human Genome and Human Rights Furthermore the project will comply with the requirements set forth in the Spanish legislation pertaining to biomedical research specifically the Law 142007 of July 3 2007 on Biomedical Research and RD 17162011 on Biobanks as well as the regulations concerning the protection of personal data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None