The Impact of the Practice of Touch-massage on the Anxiety of Patients With Hematological Disorders Hospitalized in a Protective Environment, a Randomized, Controlled Study

NCT ID: NCT02343965

Last Updated: 2016-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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Each year, 17000 cases of severe hematological diseases are diagnosed in France, with more than 6,000 of these requiring hospitalization in a protective, sterile environment. New methods, such as touch massage, have emerged in response to anxiety symptoms observed in patients in such sterile and isolated surroundings. We hypothesize that during the period of isolation, touch massage becomes a nursing care which can help the patient.

Detailed Description

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Patients with hematologic diseases (leukaemia, myeloma, lymphoma) hospitalized in a sterile area of a hematology unit for at least 3 weeks 18 to 65 years female or male Not having met the nurse, who is providing the touch-massage

Conditions

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Hematologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Touch-massage group

Patient receive 3 sessions of touch-massage (the duration of a session of touch massage is 15 minutes) ,once a week, for 3 weeks

Group Type EXPERIMENTAL

Touch-massage

Intervention Type OTHER

without touch-massage group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Touch-massage

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with hematologic diseases (leukaemia, Myeloma, lymphoma) hospitalized in a sterile area of a hematology unit for at least 3 weeks
* 18 to 65 years
* Female or male
* Not having met the nurse, who is providing the touch-massage

Exclusion Criteria

* Allergy to sweet almond oil
* Injury to the skin, at the back and / or arms and / or hands
* Cognitive impairment and / or preventing psychiatric responses to interviews and / or questionnaires
* Physical inability to take sitting in an ergonomic chair for the conduct of touch massage.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Simon A, Nizard JJ, Chevalier P, Le Gouill S, Rulleau T, Planche L, Evin A. Impact of the practice of touch-massage(R) by a nurse on the anxiety of patients with hematological disorders hospitalized in a sterile environment, a randomized, controlled study. BMC Complement Med Ther. 2024 Jan 2;24(1):1. doi: 10.1186/s12906-023-04302-3.

Reference Type DERIVED
PMID: 38167315 (View on PubMed)

Other Identifiers

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RC14_0202

Identifier Type: -

Identifier Source: org_study_id

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