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

Not Applicable

Completed

• Conditions: Hematologic Diseases
• Interventions: Other: Touch-massage

• Registration Number: NCT02343965
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

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

Study Timeline

• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-22
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Impact of touch-massage practice on patients' anxiety state, as measured by the anxiety-state questionnaire (Spielberger, CD et al, 1983) to assess the predisposition to anxiety.	3 weeks	Each patient will complete the anxiety-state questionnaire (Spielberger, CD et al, 1983) to assess the predisposition to anxiety.; The evolution of patient anxiety is calculated from the six scores of the anxiety-state scale administered before and after each of the 3 sessions of touch-massageusing the trait anxiety scale score.

Secondary Outcome Measures

Name	Time	Method
Evolution of Self Esteem, as measured by the self-esteem questionnaire	3 weeks	Each patient will complete the self-esteem questionnaire before the first and after the final session of touch-massage .
Evolution of anxiety, measured by the the anxiety-state questionnaire (Spielberger, CD et al, 1983)	3 weeks	Each patient will complete the anxiety-state questionnaire (Spielberger, CD et al, 1983) to assess the predisposition to anxiety.; The evolution of patient anxiety is calculated from the six scores of the anxiety-state scale administered before and after each of the 3 sessions of touch-massageusing the trait anxiety scale score.
Evolution of anxiety	3 weeks	Quantitative Analysis about 2 interviews recorded.In order to complement and enrich the quantitative data, two interviews will be conducted with patients receiving send the touch-massage. The data collected will be subjected to a thematic content analysis.