Impact of a Procedure With Socio-aesthetic Care on Anxiety and Pain Scale in the Early Rest of Pulmonary Transplant.

NCT03852108 | Completed

• 2 other identifiers: 2018-33IDRCB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary transplant is a valid therapy and now accept in some case of respiratory disease at final state of their evolution in selected patients according to morbidity associated. This exceptionnal procedure (+/- 350 patients per year) brings benefits in terms of survival and quality of life but stay nevertheless, an experience very gruelling, anxiogenic and painful with sometimes extend hospitalizations in intensive care and then in pneumology unit. Transplant can generate several complications like infection or rejection which can be fatal. The rate of death a year after the transplant is around 27% and whom 5 years after is around 48% according Biomedicine Agency, 2016) It's also mar of physical consequences (pain, scrars) specific to this act and expose the patient to several psychologic disruptions (decrease of body reflect, difficulty to accept organ of an other person...) So post transplant period is a painful and frightening moment. However, fear is not only sensory, it's also an affective side involving unpleasant feelings, fear and anxiety. It's a subjective and personnal experience influenced by the culture, context and other psychologic variables. The collateral effects of transplantation could be controlled through additionnal diverse comfort cares but no care protocoles can be validated, especially because of multiple confounding individuals factors. Recent studies showed that socio-aesthetic care allow an improvment of pain perception after cardiac surgery or oncology treatment. The investigators propose to evaluate by a randomized controlled study the effect of comfort care of socio-aesthetic type on anxiety and pain in the aftermath of a pulmonary transplant. In their hypothese, comfort care as socio-aethetic (body care, massage, manicure, corrective make up) could bring a personnalized answer to these patients, adapting to their complaint and waiting. It could ease the pain, anxiety, decrease level of corrective care and their side effects. In their study, socio-aesthetic care will be done by therapist with 15 years of experience and working since 2003 in the oncology unit at la Timone Hospital and since 2009 to psychiatry unit to la Conception Hospital

Conditions

Pulmonary Transplant

Outcome Measures

Primary Outcomes (2)

• Significant change of anxiety

  Anxiety will be measured by STAI-Y (State Trait Anxiety Inventory)

  Day 1, Day 7, Day 14, Day 21, Month 3, Month 6

• Significant change of pain

  Pain will be measured by the Visual Analogue Scale of pain. "no pain" to "maximum pain imaginable"

  Day 1, Day 7, Day 14, Day 21, Month 3, Month 6

Study Arms (2)

Group comfort care

EXPERIMENTAL

Socio-aesthetic care

Other: Comfort Care

Group control

NO INTERVENTION

Conventional care

Interventions

Comfort Care OTHER

Face, Hand and body care for 15 to 45 minutes

Group comfort care

Eligibility Criteria

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

You may qualify if:

• \>18 years old
• patient transfered in Respiratory Unit (Hôpital Nord, APHM) immediate following lung transplant
• Person affiliated with a social security system

You may not qualify if:

• Patient refusing post transplant following until 6 months
• History of skin allergy
• Persons deprived of their liberty, persons under guardianship or trusteeship, persons in an emergency
• Person not affiliated to a social security system or not entitled to

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique des Hôpitaux de Marseille

Marseille, 13005, France

Location

MeSH Terms

Interventions

Patient Comfort

Intervention Hierarchy (Ancestors)

Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 22, 2019
• Study Start: February 5, 2019
• Primary Completion: February 5, 2021
• Study Completion: August 9, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

FR (1)