Effects of an Early Physioterapy Program on the Emotional Well-being in Acute Hospitalized Patients

NCT06647316 | Not Yet Recruiting

• 2 other identifiers: 00145607
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Illness

Keywords

Well-being; Physiotherapy; Biopsychosocial Health Impact; Hospitalization

Outcome Measures

Primary Outcomes (1)

• WHO-5 Well-Being Index

  Emotional well-being will be assessed using the WHO-5 scale, a 5-item questionnaire that gathers ordinal qualitative data. Scores range from 0 to 25, where 25 represents the highest level of emotional well-being.

  The evaluation period will commence on the date of the initial documented progression and will conclude at least four days after the completion of the physical therapy sessions, or up to six days after the initial assessment.

Secondary Outcomes (4)

• EQ-5D-5L Scale

  The evaluation period will commence on the date of the initial documented progression and will conclude at least four days after the completion of the physical therapy sessions, or up to six days after the initial assessment.

• Functional Ambulation Classification (FAC) Scale. Gait capacity

  The evaluation period will commence on the date of the initial documented progression and will conclude at least four days after the completion of the physical therapy sessions, or up to six days after the initial assessment.

• Critical Care Family Needs Inventory (CCFNI)

  The evaluation period will commence on the date of the initial documented progression and will conclude at least four days after the completion of the physical therapy sessions, or up to six days after the initial assessment.

• Patient satisfaction: Study-Specific Questionnaire

  The evaluation period will commence on the date of the initial documented progression and will conclude at least four days after the completion of the physical therapy sessions, or up to six days after the initial assessment.

Study Arms (1)

Intervention Group: Physiotherapy for Emotional Well-Being

EXPERIMENTAL

The subjects will receive a minimum of four physiotherapy sessions in the various units where they are currently undergoing treatment. The treatment will be tailored to the specific pathology of each patient, in accordance with medical guidelines.

Other: Physiotherapy

Interventions

Physiotherapy OTHER

The subjects will receive the first physiotherapy session : early mobilization, postural and joint ergonomics, sensory stimulation, temporal-spatial orientation and health education for the patient and the main caregiver are carried out.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 subject's abilities.The second physical therapy session incorporates taste and preference-based elements into the therapy itself. The third physiotherapy session is planned to take place in the physiotherapy unit. Following the individualized session, group interaction is encouraged, whether with other patients, the rehabilitation team and/or the patient's primary caregiver.In the fourth physiotherapy session, it is promoted therapeutic compliance.

Intervention Group: Physiotherapy for Emotional Well-Being

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer Adults (18 years of age or older) that must provide written informed consent to participate in the study.
• Hospitalization Requirements
• Participants must have been hospitalized in one of the hospital medical service departments for a minimum of 96 hours prior to enrollment.Eligibility for Physiotherapy:
• Participants must be deemed eligible for physiotherapy treatment during their hospital stay, as determined by the medical team.
• Cognitive Function: Participants must have a Mini-Mental State Examination (MMSE) score of 24 points or higher, indicating sufficient cognitive function.
• Participants must have received a minimum of 4 physiotherapy sessions during their hospital stay.
• A primary caregiver must be identified and available to participate in the study, although the caregiver does not need to be a family member.

You may not qualify if:

• Language Impairment: Patients with a language disorder that affects their ability to communicate effectively, thereby preventing them from providing informed consent or fully participating in the study.
• Language Barriers: Patients who encounter substantial linguistic barriers that cannot be overcome with the provision of interpretation or translation services, thus limiting their ability to comprehend or fully engage in the study.
• Patients Undergoing Specific Physiotherapeutic Treatments: Patients currently enrolled in physiotherapy programs standardized by the hospital's rehabilitation service for the following conditions: movement recovery, knee prosthesis, hip prosthesis, cardiac surgery, thoracic surgery, and bariatric surgery.

Sponsors & Collaborators

• Sierra Varona SL: lead

Related Publications (6)

• Raurell-Torreda M, Arias-Rivera S, Marti JD, Frade-Mera MJ, Zaragoza-Garcia I, Gallart E, Velasco-Sanz TR, San Jose-Arribas A, Blazquez-Martinez E; Grupo MOviPre. Degree of implementation of preventive strategies for post-ICU syndrome: Multi-centre, observational study in Spain. Enferm Intensiva (Engl Ed). 2019 Apr-Jun;30(2):59-71. doi: 10.1016/j.enfi.2018.04.004. Epub 2018 Jun 28. English, Spanish.

  PMID: 29960855 BACKGROUND

• Steenbruggen RA, Maas MJM, Hoogeboom TJ, Brand PLP, van der Wees PJ. A framework to improve quality of hospital-based physiotherapy: a design-based research study. BMC Health Serv Res. 2023 Jan 14;23(1):34. doi: 10.1186/s12913-023-09062-x.

  PMID: 36641465 BACKGROUND

• Lobo A, Ezquerra J, Gomez Burgada F, Sala JM, Seva Diaz A. [Cognocitive mini-test (a simple practical test to detect intellectual changes in medical patients)]. Actas Luso Esp Neurol Psiquiatr Cienc Afines. 1979 May-Jun;7(3):189-202. No abstract available. Spanish.

  PMID: 474231 BACKGROUND

• Cabases JM. [The EQ-5D as a measure of health outcomes]. Gac Sanit. 2015 Nov-Dec;29(6):401-3. doi: 10.1016/j.gaceta.2015.08.007. No abstract available. Spanish.

  PMID: 26505321 BACKGROUND

• Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40. doi: 10.1093/ptj/64.1.35.

  PMID: 6691052 BACKGROUND

• Giordano A, Ferrari G, Radice D, Randi G, Bisanti L, Solari A; POSMOS study. Health-related quality of life and depressive symptoms in significant others of people with multiple sclerosis: a community study. Eur J Neurol. 2012 Jun;19(6):847-54. doi: 10.1111/j.1468-1331.2011.03638.x. Epub 2012 Jan 10.

  PMID: 22233289 BACKGROUND

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Elena F Fernández, M.Sc.

CONTACT

+34627006200; fisiocoimbra7@gmail.com

Irene F Cañedo, M.Sc.

CONTACT

+34606925504; irene.canedoperez@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This project employs a quasi-experimental, analytical, longitudinal, prospective, single-group study design.

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 17, 2024
• Study Start: October 14, 2024
• Primary Completion: May 15, 2025
• Study Completion: August 15, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10