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Completed

NCT Number: NCT02343965

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, 44093, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Touch-massage

Other

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.

    Time frame: 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 outcomes

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

    Time frame: 3 weeks

    Each patient will complete the self-esteem questionnaire before the first and after the final session of touch-massage .

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

    Time frame: 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.

  3. Evolution of anxiety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: TANDHEMS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 22, 2015
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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