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

Hematologic Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343965
• Other study ID #: RC14_0202
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: January 20, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hematologic Diseases

Intervention

Other:
• Touch-massage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks	No
Secondary	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 .	3 weeks	No
Secondary	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.	3 weeks	No
Secondary	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.	3 weeks	No