Back to resultsThe Impact of the Practice of Touch-massage on the Anxiety of Patients With Hematological Disorders Hospitalized in a Protective Environment, a Randomized, Controlled Study (TANDHEMS)
Primary Purpose
Hematologic Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Touch-massage
Sponsored by
About this trial
This is an interventional supportive care trial for Hematologic Diseases focused on measuring Touch-massage, anxiety, leukemia, haematology, cancerology, supportive care, complementary therapy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Touch-massage group
without touch-massage group
Arm Description
Patient receive 3 sessions of touch-massage (the duration of a session of touch massage is 15 minutes) ,once a week, for 3 weeks
Outcomes
Primary Outcome Measures
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.
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
Evolution of Self Esteem, as measured by the self-esteem questionnaire
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)
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
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.
Full Information
NCT ID
NCT02343965
First Posted
January 12, 2015
Last Updated
January 20, 2016
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02343965
Brief Title
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
Acronym
TANDHEMS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases
Keywords
Touch-massage, anxiety, leukemia, haematology, cancerology, supportive care, complementary therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Touch-massage group
Arm Type
Experimental
Arm Description
Patient receive 3 sessions of touch-massage (the duration of a session of touch massage is 15 minutes) ,once a week, for 3 weeks
Arm Title
without touch-massage group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Touch-massage
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Evolution of Self Esteem, as measured by the self-esteem questionnaire
Description
Each patient will complete the self-esteem questionnaire before the first and after the final session of touch-massage .
Time Frame
3 weeks
Title
Evolution of anxiety, measured by the the anxiety-state questionnaire (Spielberger, CD et al, 1983)
Description
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.
Time Frame
3 weeks
Title
Evolution of anxiety
Description
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.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
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
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