Treatment with oxygen of headaches after electroshock therapy

Phase 1

Conditions: Headaches occuring after electro conculsion therapy.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2018-001763-23-NL

Lead Sponsor: Reinier van Arkel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 68

Inclusion Criteria

Age older than 18
Indication for ECT for psychiatric illness.
Hospitalized in the department ZPO of the Reinier van Arkel groep
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

COPD
Current use of bleomycine, or in the past 12 months
Patients with a custody measure
Patients who are mentally incompetent regarding the decision of participation in the study, or undergo trial operations
Patients who suffer from panic attacks
Patients with a VRS-score equal or less than 1 after ECT
Patients with a VRS-score more than 1 before ECT

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Reduction of headache complaints after electro convulsion therapy. Effect of treatment is defined as a reduction of headache on the VRS (verbal rating scale), from 2 or 3 to equal or less than 1. ;Secondary Objective: Time untill the treatment effect. It is expected that oxygen therapy will result in an imediate reduction of headache, as it is the case in treatment of cluster headache. <br><br>Duration of treatment effect. It is expected that reduction of headache will last for at least 2 hours. ;Primary end point(s): Reduction of headache from a score of 2 or 3 on the verbal rating scale (VRS) to equal or less than 1.. ;Timepoint(s) of evaluation of this end point: Treatment effect will be measured after ECT, after oxygen therapy and after 60 and 120 minutes after oxygen therapy.

Secondary Outcome Measures