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98 CHAPTER 5 CHRONIC TTH ANALYSIS BY EMG AND GSR BIOFEEDBACK

5.5.4 PROPOSED FRAMEWORK
The framework has been explained with the help of different diagrams.

5.6 EXPERIMENTS AND RESULTS—STUDY PLOT
5.6.1 STUDY DESIGN AND SOURCE OF DATA
The whole clinical trial was conducted in a randomized, single blinded, prospective controlled
environment.
From different neurology clinics, various subjects were recruited, and the psychology of Dev
Sanskriti Vishwa Vidyalaya, Shantikunj Haridwar were used for biofeedback therapy.

5.6.2 STUDY DURATION AND CONSENT FROM SUBJECTS
Subjects were recruited from mid-January 2017 up to May 2018 and followed until July 2018. Consent
from each subject was obtained before recruiting in the trials. An Informed-Consent Form approved by
the ethical committee was completed by the subjects and clinical authentication for the trial was
obtained. Ethical clearance was granted by the ethical committee formed by the University.

5.6.3 SAMPLING DESIGN AND ALLOCATION PROCESS
Simple random sampling was used with the lottery method for allocation of subjects to seven groups.
Subjects with TTH were enrolled in the study. Subjects who did not consent and who did not meet the
eligibility criteria were excluded from the study. The rest of the subjects were randomized using the
lottery method for allocation.
Chits numbered 1 to 7 were placed in a bowl and the subjects were asked to pick the chits. Subjects
with the following chit numbers were allocated to the corresponding groups:

Grp 1: EMG auditory biofeedback (EMGa)
Grp 2: GSR auditory (GSRa)
Grp 3: EMG visual biofeedback (EMGv)
Grp 4: GSR visual (GSRv)
Grp 5: EMG auditory-visual biofeedback (EMGav)
Grp 6: GSR auditory-visual (GSRav)
Grp 7: Control group.

5.6.4 SAMPLE SIZE
The formula used for calculating the sample size was as follows:
N ¼ 2 Zα + ZβÞ2 pq= p1 p2Þ2
ð
ð
Probability of Type I error was set at .05.
Power of the study was set at 80% (0.8).