DOI: 10.5281/zenodo.4686867
title: Floatation-REST for Chronic Pain

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