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

NCT02343965 | Completed DMC

• 1 other identifier: RC14_0202
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematologic Diseases

Keywords

Touch-massage; anxiety; leukemia; haematology; cancerology; supportive care; complementary therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Evolution of Self Esteem, as measured by the self-esteem questionnaire

  3 weeks

• Evolution of anxiety, measured by the the anxiety-state questionnaire (Spielberger, CD et al, 1983)

  3 weeks

• Evolution of anxiety

  3 weeks

Study Arms (2)

Touch-massage group

EXPERIMENTAL

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

Other: Touch-massage

without touch-massage group

NO INTERVENTION

Interventions

Touch-massage OTHER

Touch-massage group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Related Publications (1)

• 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.

  PMID: 38167315 DERIVED

MeSH Terms

Conditions

Hematologic Diseases; Anxiety Disorders; Leukemia

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Mental Disorders; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 22, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 21, 2016

Record last verified: 2015-01