Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05570773 |
| Other study ID # |
Relaxation |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 12, 2021 |
| Est. completion date |
July 25, 2021 |
Study information
| Verified date |
October 2022 |
| Source |
Cukurova University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The effect of peer support and progressive relaxation exercise programs on midwifery
students' sleep and anxiety levels in the COVID-19 pandemic was investigated in the present
research. One hundred and four subjects were found eligible for the study according to the
inclusion criteria, and they were grouped into three: the peer support program group (PSP)
(n=34), the progressive relaxation exercise group (PRE) (n=35), and control group (n=35). The
PRE group was given an online relaxation exercise program. The PSP group was given an online
peer support program. The data collection tools included a descriptive data form, State-Trait
Anxiety Inventory (STAI-I-II), and Pittsburgh Sleep Quality Index (PSQI). The scores of the
groups that they obtained from the pre-test application of the STAI-I and PSQI did not yield
a statistically significant difference. The scores that PRE and PSP groups obtained from the
post-test application of the STAI-I and PSQI were lower than the score that was obtained by
the control group on the post-test application of the measures, and difference was evaluated
to be significant. Although the mechanisms of action of these two methods are different, it
has been observed that they have similar effects in improving anxiety levels and sleep
quality.
Description:
This is a randomized, controlled intervention trial. It was carried out according to CONSORT
guidelines between February 12 and March 28, 2021 with students who were studying midwifery
at a state university.
Randomization Three hundred and sixty students from the midwifery department made up the
population of the study, and the sample consisted of three hundred and thirteen students that
agreed to join the study. We excluded some subjects from the study according to the exclusion
criteria. The remaining one hundred and forty-four subjects were randomly divided into groups
as PRE, PSP, and controls through randomization by assigning consecutive numbers to them via
computer software (https://www.randomizer.org/). Accordingly, forty-eight students were
assigned to the PRE group, forty-eight to the PSP group, and forty-eight to the control
group. After the randomization step, 8 students from the PRE group, 10 from the PSP group,
and 12 from the control group, who did not want to continue, were excluded from the study.
During the follow-up period, 3 students from the PRE group and 2 students from the PSP group
were excluded because they did not achieve 80% attendance. Since five subjects (two, PRE
group; two, PSP group; one, control group) were unavailable during the data analysis stage,
their final measurements could not be made, and therefore they were excluded. The study was
completed with a total of 104 students, including 35 in the PRE group, 34 in the PSP group,
and 35 in the control group. First, all 3 groups filled out the questionnaires as a pre-test
application. At the end of 30 days, the groups filled out the questionnaires as a post-test.
It took approximately 10-15 minutes to fill out the questionnaires.
Intervention groups PRE group The importance of the exercise and how it should be done were
explained by the researcher Mixed teaching methods, including lecturing, demonstration,
question-answer, and discussion were, used as education methods. The sessions were carried
out online by a researcher who is an expert in the field of PRE for 30 minutes every day
between 21:00 and 21:30 before bedtime for 30 days.
Steps of progressive relaxation exercises: This progressive relaxation technique developed by
Jacobson is one of the easiest to learn and practice. PRE is a holistic approach based on the
controlled, voluntary, regular, and successive active contraction and passive relaxation of
major muscle groups. The person is asked to wear comfortable clothes, relax as much as
possible, and breathe slowly and deeply. This technique, which can be applied sitting or
lying down, can also be performed with music to contribute to the relaxation of the
individual.
The education begins with diaphragmatic breathing exercises and continues with PRE. In this
exercise, the patient positions one of his/her hand on his/her chest and the other on the
mid-abdomen, and then told to breathe in slowly and deeply through the nose, counting to 4,
hold the air counting to 4 again, and exhale by pursing lips while exhaling. In diaphragmatic
breathing, the abdomen is expected to be inflated as much as possible while breathing in
through the nose. While performing the exercise, the sensory, visual, and tactile stimuli
given to the patient are gradually reduced and made difficult. The exercise is repeated 2-3
times, and then the patient is allowed to rest between the sessions.
PRE is applied from the bottom to the top, starting from the feet to the lower extremity,
trunk, upper extremity, and facial muscles, respectively. The person is asked to relax and
start by giving their attention to their feet when they are ready, and focus on their feet
for a while and perceive how they feel. The person is told to take a deep breath and slowly
tighten their foot for 10-20 seconds, and then release the foot muscles while exhaling and
feel the loose and flexible state of the foot for 30-40 seconds. During relaxation, deep,
slow breathing is continued while moving the upper part of the body. A total of 15
zones/muscle groups are exercised with one repetition, without giving a break. After each
contraction and relaxation process, slow and deep diaphragmatic breathing exercises should be
performed several times before moving on to a new muscle group. After all the muscles are
contracted and released in turn, now, all the muscles are contracted simultaneously while
breathing in and are simultaneously released again while exhaling. Then, the exercises are
completed with slow and deep diaphragmatic breathing.
PSP group A researcher and peer tutors met students in an online session for 30 minutes every
day between 21:00 and 21:30 before bedtime for 30 days. These sessions focused on academic
problem solving and academic encouragement of students. In addition, peer tutors and students
shared their contact information and continued their sharing by talking on the phone and
messaging in the chat group 24/7.
Selection and education of peer tutors: 5 peers with strong communication skills and high
academic achievement were selected among the 4th-year volunteer students. These 5 volunteers
were selected among students who were not included in the sample, had an appropriate level of
anxiety (anxiety score ≤36), and had good sleep quality (PSQI score ≤5). A theoretical and
practical session was held with them. In these sessions, peer-supported education was
explained and necessary information was given about its purpose and how it was performed.
Peer support: It has been suggested that peer support provides an alternative way for
students to learn and makes a positive contribution to both academic and psychosocial aspects
of higher education. Peer academic support involves academic encouragement (support for
lowering exam-related stress and motivation for lessons) and solving students' academic
problems (answering questions about lessons, sharing study habits, studying together,
answering questions about assignments).
Control group The students who formed the control group through randomization were given
information about the research, and then they submitted informed consent. Control group
students were given the same questionnaire as a pre-and-post-test applied in the intervention
groups, but no intervention was applied.
Data collection Data collection tools included the State and Trait Anxiety Inventory, which
was developed by Spielberger, (STAI-I-II), the Pittsburgh Sleep Quality Index (PSQI), and a
descriptive information form designed to collect socio-demographic information.
