This was a 2-group randomized controlled field trial. The study population comprised of all pregnant females, who referred to the only urban healthcare center in Nehbandan, Iran, during year 2015. Sampling was done purposively based on the following eligibility criteria: a gestational age of 4 to 16 weeks, full consciousness, no known mental disorders, such as anxiety and depression, (based on medical records), no known muscular disorders, and agreement to participate in the study. Exclusion criteria were voluntary withdrawal from the study, absence from BRR training sessions, failure to perform relaxation exercises for 5 sessions, hospitalization, travel, and death. Recruited females were allocated to control and intervention groups through block randomization with a 4-person block size.
Sample size was calculated based on the results of a pilot study (on 10 females) and via the sample size calculation formula for the comparison of 2 means. With an
X̅1of 4.66, an X̅1 of 2.88, anS1of 1.64, anS2of 1.41, a confidence level of 0.99, and a power of 0.90, sample size for each group was estimated as 22. Considering an attrition rate of 20%, sample size was increased to 27 for each group, i.e. 54 cases in total.
Data collection tools were a demographic questionnaire, a clinical characteristics questionnaire, the fatigue severity scale (FSS), and a relaxation exercise performance checklist. The items of the demographic questionnaire were on participants’ age, gender, marital status, educational status, and employment status, while the items of the clinical characteristics questionnaire were related to their history of hypertension and diabetes mellitus, number of children, and number of previous abortions. The FSS included 9 items scored on a Likert-type scale from 1 (“the lowest possible fatigue”) to 7 (“the highest possible fatigue”). Therefore, the total score of FSS was 9 to 63 (
13). The reliability of FSS was confirmed by previous studies with a Cronbach’s alpha value of 0.94, 0.91, and 0.81 (
19-
21). Moreover, the scale was reported to have satisfactory face and content validity (
20,
21).
Participants were primarily asked to complete the demographic questionnaire, the clinical characteristics questionnaire, and FSS. Next, the fourth author personally trained each woman in the intervention group with BRR, in 3 training sessions using a training video clip. The number of training sessions could be increased to achieve participants’ complete learning of BRR. After the training sessions, the fourth author asked the intended participant to perform BRR in order to ensure of her ability to independently and accurately perform BRR. Thereafter, each participant was asked to listen to a BRR instruction sound file and perform BRR for 15 to 20 minutes twice daily for 1 month. The instructions were as follows:
- Assume a comfortable position.
- Close your eyes softly.
- Gradually relax all body muscles from the toes to the head. Attempt to keep muscles relaxed.
- Inhale through the nose, be aware of your breathing, and slowly exhale through the mouth. During exhalation, say the word “one”. Breathe normally and comfortably.
- Repeat this exercise 15 to 20 minutes while keeping all muscles relaxed. Finally, open your eyes softly and remain in the same position for several minutes.
- Do not feel worried about whether you have reached deep relaxation or not. Just, let relaxation happen at its own pace. In case of disturbing thoughts, attempt to overlook them and to be indifferent towards them (
22).
In order to remind participants of performing the BRR regularly, both telephone and face-to-face contacts were made with them, and their family members were asked to remind them, and asked them to complete the relaxation exercise performance checklist. Females in the control group did not receive any relaxation-related training. The level of participants’ fatigue in both groups was reassessed immediately after the 30-day intervention.
The SPSS software (v. 21.0) was used for data analysis through the paired-sample t, the independent-sample t, and the Chi-square test as well as the one-way analysis of variance. The level of significance in all statistical tests was set at below 0.05.
This study was approved by the Ethics Committee of Gonabad University of Medical Sciences, Gonabad, Iran (with the approval code of GMUFEC1393.10). Necessary permissions for the study were obtained from Gonabad and Birjand Universities of Medical Sciences, Gonabad and Birjand, Iran, as well as healthcare authorities of Nehbandan, Iran. Written informed consent was obtained from all participants.