Hematologic DiseasesTANDHEMSNCT02343965
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
A study testing Touch-massage in people with Hematologic Diseases, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- Touch-massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Conditions
- Hematologic Diseases
- Being tested
- Touch-massage
- Keywords
- Touch-massage, anxiety, leukemia, haematology, cancerology, supportive care, complementary therapy
- Medical subject headings
- Hematologic Diseases, Anxiety Disorders, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Touch-massageOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Touch-massage |
| without touch-massage group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (3)
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 .
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343965
- Sponsor's protocol ID
- RC14_0202
- Acronym
- TANDHEMS
- Status last verified
- Jan 2015
- First submitted
- 12 Jan 2015
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38167315
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02343965
- Acronym / sponsor ID
- TANDHEMS / RC14_0202
- Conditions
- Hematologic Diseases
- Keywords
- Touch-massage, anxiety, leukemia, haematology, cancerology, supportive care, complementary therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Touch-massage group | Experimental | Other: Touch-massagePatient receive 3 sessions of touch-massage (the duration of a session of touch massage is 15 minutes) ,once a week, for 3 weeks |
| without touch-massage group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Touch-massage | Other | Touch-massage group |
Primary outcome
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.
3 secondary outcomes
Evolution of Self Esteem, as measured by the self-esteem questionnaire
Time frame: 3 weeks
Evolution of anxiety, measured by the the anxiety-state questionnaire (Spielberger, CD et al, 1983)
Time frame: 3 weeks
Evolution of anxiety
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Derived from this study: PubMed 38167315Simon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Touch-massage in people with Hematologic Diseases, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02343965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.