Mizrahi 2012.

Study characteristics
Methods	RCT Setting: Hadassah Medical Center in Jerusalem Study period: NS The study presents results for the IBD cohort as a whole, does not separate between CD and UC. Where separate data do exist they are presented below.
Participants	Inclusion criteria: (1) confirmed diagnosis of IBD for at least 6 months prior to recruitment; (2) age over 18 years; (3) suffering from an "active" disease according to the "Disease Activity Questionnaire", by meeting 1 of the following criteria: more than 5 bowel movements a day, more than 1 hospitalisation a year over the previous 2 years, and had either suffered a fistula during the previous year or was using corticosteroids; (4) provided informed consent; (5) fluent in the Hebrew language Exclusion criteria: (1) expected surgery in the following 2 months; (2) diagnosed as suffering from an active psychosis or from active major depression (due to the hazard of psychotic‐symptom‐abreactions this would be contraindicative for relaxation); (3) undergoing psycho‐pharmacotherapy (anti‐anxiety, antidepression, or antipsychotic); (4) already participating in another research study; (5) acquainted with and already practicing relaxation techniques Age (mean ± SD): IG: 35.56 (14.45); CG: 35.57 (12.76) Sex (M/F): IG: 9/9: CG: 13/8 Site of disease: NS Use of concurrent medication: IG: without medication 2, corticosteroids 3, 5‐ASA 13, immunosuppressive drugs 5, alternative treatment 5 CG: without medication 4, corticosteroids 1, 5‐ASA 12, immunosuppressive drugs 8, alternative treatment 10 Disease duration: NS Disease activity: active Number randomised: IG: 28; CG: 28 Number reaching end of study: IG: 18 (CD: 10, UC: 8); CG: 21 (CD: 14, UC: 7) Number analysed: IG: 18; CG: 21 Postrandomisation exclusion: 17 IG: 10 (medical reasons, time constraints, failing to return questionnaires) CG: 7 (failing to return questionnaires)
Interventions	IG: Relaxation training. The intervention consisted of 3 individual relaxation‐training sessions at 2‐week intervals. Relaxation training with guided imagery served as the basis for the three 50‐minute treatment sessions. Each treatment session included: (1) a relaxation exercise with guided imagery, (2) a brief review of the relaxation monitoring forms, used to assess difficulties, and (3) a discussion of any problems the participant may have experienced whilst attempting to achieve relaxation. Each participant received an audio disc and was asked to continue to practice at home. Participants were advised to practice at least once a day during the 5‐week period of the study and to record the frequency of home practice in the provided log sheets. CG: Waitlist. The control participants on the waiting list were assessed at baseline and approximately 5 weeks later at the end of the waitlist period. Participants completed symptom‐monitoring diaries both at baseline and at the end of the trial. After completion of the diaries and following analysis of the collected data, the control participants were offered treatment in a group setting.
Outcomes	Length of intervention: 5 weeks Primary outcomes: Pain intensity was measured using 10‐centimetre VAS. The time scale referred to the 24 hours prior to assessment. VAS measurements evaluate changes in a person’s subjective perception. The overall scores for each measurement ranged from 0 to 10, with a higher score reflecting a worse state as perceived by the participant. Secondary outcomes: Anxiety/depression
Notes	Funding source: NS Conflict of interest: NS Author contact details: erang@szmc.org.il
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not mentioned. We contacted the authors but received no response.
Allocation concealment (selection bias)	Unclear risk	Not mentioned. We contacted the authors but received no response.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible for this type of intervention
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not mentioned. We contacted the authors but received no response.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data were presented for all participants who completed the study; however, baseline characteristics do not include the participants who dropped out.
Selective reporting (reporting bias)	Low risk	All outcomes were presented in the results.
Other bias	High risk	"Statistically significant differences were found on the pain measurements between the groups at pre‐treatment, with the treatment group demonstrating higher levels of pain"