Floatation-REST for Chronic Pain

This dataset was acquired at Hannover Medical School, Hannover, Germany. The study complied with the Declaration of Helsinki, and was approved by the local ethics committee. All subjects gave written informed consent, and consent to publish their data anonymously. The study was registered at ClinicalTrials.gov (NCT03584750).

We conducted a single-blind, randomized clinical trial comparing floatation-REST (restricted environmental stimulation therapy) with an indistinguishable placebo, and a wait-list control. A total of 99 patients with a diagnosis of chronic pain disorder with psychological and somatic factors (ICD-10-GM code F45.41) were randomly assigned to one of the three groups. Patients in the intervention and the in the placebo group underwent five sessions lasting 60-90 minutes; each session separated by approximately four days. The placebo treatment was delivered in the same floating tank, but controlled for effortless floating and environmental stimulus restriction. The wait-list control group did not receive any additional treatment. Participants in all three groups where asked not to start any new therapy, and to continue their prescribed treatments at the time of enrollment.

Further details on the inclusion and exclusion criteria, outcomes and measures, as well as study dates can be found on the trial registration page at ClinicalTrials.gov. This dataset contains the raw data as well as necessary scripts for reproducing the results of this study. The scripts for calculating questionnaire scores are not included within this dataset as they include proprietary data. However, we provide the output of the respective "data_extraction.py" scripts with calculated scores.

Data structure

• raw
  • sub_i: Raw data of subject i
    • patient.txt: contains either 1 (male) or 2 (female)
    • questionnaires_0.json: Baseline long-term questionnaires. Includes participant's age at recruitment
    • questionnaires_1.json: long-term questionnaires 1 week after the last session
    • questionnaires_2.json: long-term questionnaires 12 weeks after the last session
    • questionnaires_3.json: long-term questionnaires 24 weeks after the last session
    • visit_1: participants gave written informed consent at this visit
      • physio.json: physiological measurements
      • symptoms: electronic drawings
      • si_v0.png: symptom i front view
      • si_v1.png: symptom i back view
      • records.json: includes symptoms description
    • visit_2-6: five floatation-REST or placebo sessions
      • float_duration.txt: float duration in minutes
      • physio_0.json: physiological measurements before the session
      • physio_1.json: physiological measurements after the session
      • questionnaires_0.json: short-term questionnaires before the session
      • questionnaires_1.json: short-term questionnaires after the session
      • symptoms_0: electronic drawings before the session (files as above)
      • symptoms_1: electronic drawings after the session (files as above)
      • sensations: electronic drawings of unusual sensations during the session (files as above)
      • remarks.txt: contains information about further unusual sensations or whether the lid was opened
    • visit_7: one week after the last session
      • physio.json: physiological measurements
      • symptoms: electronic drawings (files as above)
• analyses: scripts for reproducing the results
  • 00_excluded_subjects: participants who dropped out of the study
  • 00_subjects: all other participants
  • extract_drawings.sh: loop through the participants to convert all drawings from png to nifti, and merge and binarise them (for calculation of pain area and WPI)
  • Jpng2nii.py: script to convert drawings from png to nii
  • JWPI.sh: calculates WPI from electronic drawings
  • JWPI.py: used to calculate WPI by JWPI.sh
  • WPI_3D_back.nii.gz: 4D image containing masks of the 19 regions defined in the WPI (back view)
  • WPI_3D_front.nii.gz: 4D image containing masks of the 19 regions defined in the WPI (front view)
  • baseline
    • data.csv: output from data_extraction.py
    • data_complete.csv: output from data_extraction.py
    • data_extraction.py: creates a csv with all data required for baseline calculations
    • statistical_tests.py: computes baseline statistical analyses
  • long-term
    • data.csv: output from data_extraction.py
    • data_complete.csv: output from data_extraction.py
    • data_extraction.py: creates a csv with all data required for long-term calculations
    • statistical_tests.py: computes long-term statistical analyses and plots
  • short-term
    • data.csv: output from data_extraction.py
    • data_complete.csv: output from data_extraction.py
    • data_extraction.py: creates a csv with all data required for short-term calculations
    • statistical_tests.py: computes short-term statistical analyses and plots

Subjects and groups
A: Floatation-REST
B: Placebo floating
C: Wait-list control

    01    A
    02    A
    03    A
    04    A
    05    C
    06    C
    07    B
    08    C
    09    B
    10    C
    11    A
    12    B
    13    A
    14    C
    15    C
    16    B
    17    B
    18    A
    19    C
    20    B
    21    B
    22    A
    23    B
    24    A
    25    B
    26    C
    27    A
    28    B
    29    B
    30    B
    31    A
    32    C
    33    A
    34    C
    35    B
    36    C
    37    B
    38    A
    39    C
    40    B
    41    A
    42    B
    43    B
    44    A
    45    A
    46    B
    47    C
    48    B
    49    C
    50    C
    51    A
    52    B
    53    B
    54    C
    55    A
    56    B
    57    A
    58    C
    59    C
    60    C
    61    A
    62    B
    63    A
    64    B
    65    B
    66    A
    67    C
    68    B
    69    A
    70    B
    71    B
    72    C
    73    A
    74    C
    75    B
    76    C
    77    C
    78    A
    79    C
    80    C
    81    A
    82    C
    83    B
    84    B
    85    C
    86    A
    87    B
    88    C
    89    B
    90    B
    91    A
    92    C
    93    B
    94    A
    95    A
    96    A
    97    A
    98    B
    99    B

Missing data

• 09: Second follow-up
• 29: Visit_1 physio
• 31: Visit_3_post physio
• 42: Visit_7
• 47: Visit_1 physio
• 51: Visit_7
• 66: Visit_7
• 67: Incomplete first follow-up. Visit_1 physio
• 83: Visit_7
• 86: Visit_7
• 90: Visit_7
• 93: Visit_1 physio
• 96: Visit_7
• 97: Visit_7
• 98: Visit_7

Dropouts

• 01: Operation
• 06: Loss of interest
• 07: Illness (GI)
• 10: Other study
• 12: Job
• 13: Loss of interest
• 17: Loss of interest
• 21: Loss of interest
• 27: Contact lost
• 37: Loss of interest
• 44: Haemorrhoids
• 46: Too cold
• 52: Herpes zoster
• 58: Loss of interest
• 63: Otitis media
• 64: Contact lost
• 65: Pregnancy
• 68: Illness of relative
• 69: Open psoriasis
• 75: Loss of interest
• 79: Loss of interest
• 80: Loss of interest
• 91: Illness of relative
• 93: Illness