NCT05570773

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

October 3, 2022

Last Update Submit

October 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • State and Trait Anxiety Inventory

    questionnaire

    16 weeks

Secondary Outcomes (1)

  • Pittsburgh Sleep Quality Index

    16 weeks

Study Arms (3)

peer support program

EXPERIMENTAL

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.

Other: peer support program

progressive relaxation exercise group

EXPERIMENTAL

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.

Other: peer support program

control group

NO INTERVENTION

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.

Interventions

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 (Hogan, Fox, Barratt-See 2017). 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)

Also known as: progressive relaxation exercises program
peer support programprogressive relaxation exercise group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • did not have sleep apnea,
  • did not musculoskeletal disease
  • did not cardio-pulmonary disease
  • did not psychiatric disease
  • did not use drugs, cigarettes, alcohol
  • SAI score of \>36 (anxiety)
  • PSQI score of \>5 (poor sleep quality)

You may not qualify if:

  • Clinical diagnosis of sleep apnea
  • musculoskeletal disease
  • cardio-pulmonary disease
  • psychiatric disease
  • history of drugs, smoking, and alcohol
  • SAI score of ≤36 (no anxiety),
  • PSQI score of ≤5 (good sleep quality)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Balcalı, 01 330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersParasomnias

Condition Hierarchy (Ancestors)

Mental DisordersSleep Wake DisordersNervous System Diseases

Study Officials

  • Fatma TOPKARA, Dr.

    Eskişehir Osmangazi University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 7, 2022

Study Start

February 12, 2021

Primary Completion

March 28, 2021

Study Completion

July 25, 2021

Last Updated

October 7, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations