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

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ClinicalTrials.gov Identifier: NCT03852108
Recruitment Status : Unknown
Verified January 2019 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Not yet recruiting
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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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


Condition or disease Intervention/treatment Phase
Pulmonary Transplant Other: Comfort Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Impact of a Procedure With Socio-aesthetic Care on Anxiety and Pain Scale in the Early Rest of Pulmonary Transplant.
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group comfort care
Socio-aesthetic care
 Other: Comfort Care
Face, Hand and body care for 15 to 45 minutes
No Intervention: Group control
Conventional care


Outcome Measures
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Primary Outcome Measures :
  1. Significant change of anxiety [ Time Frame: Day 1, Day 7, Day 14, Day 21, Month 3, Month 6 ]
    Anxiety will be measured by STAI-Y (State Trait Anxiety Inventory)

  2. Significant change of pain [ Time Frame: Day 1, Day 7, Day 14, Day 21, Month 3, Month 6 ]
    Pain will be measured by the Visual Analogue Scale of pain. "no pain" to "maximum pain imaginable"


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852108


Contacts
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Contact: Laure MARCEL, IC + 33 4 919 66 139 laure.marcel@ap-hm.fr

Locations
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France
Assistance Publique des Hôpitaux de Marseille
Marseille, France, 13005
Contact: Martine REYNAUD-GAUBERT, Pr    + 33 4 919 66 145    MartineLouise.REYNAUD@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03852108    
Other Study ID Numbers: 2018-33
IDRCB ( Other Identifier: 2018-A01968-47 )
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: January 2019

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