AnxietyNCT05570773
Effects of Peer Support and Progressive Relaxation Exercises on Sleep Quality and Anxiety
A study testing peer support program in people with Anxiety and Sleep Disturbance, run by Cukurova University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Sleep Disturbance
- What is being tested?
- peer support program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2021to 25 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Peer Support and Progressive Relaxation Exercises on Sleep Quality and Anxiety in Midwifery Students During COVID-19 Pandemic: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Anxiety, Sleep Disturbance
- Being tested
- peer support program
- Medical subject headings
- Anxiety Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peer support programOther
Also called progressive relaxation exercises program
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State and Trait Anxiety Inventory
questionnaire
Measured: 16 weeks
Secondary outcomes (1)
Pittsburgh Sleep Quality Index
questionnaire
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start12 Feb 2021
- Primary completion28 Mar 2021
- Study completion25 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif DAĞLI, Cukurova University
- Investigators
- Fatma TOPKARA, Dr., Study chair, Eskişehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570773
- Sponsor's protocol ID
- Relaxation
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peer Support and Progressive Relaxation Exercises on Sleep Quality and Anxiety in Midwifery Students During COVID-19 Pandemic: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05570773
- Acronym / sponsor ID
- Relaxation
- Conditions
- Anxiety, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 28 Mar 2021 (actual)
- Study completion
- 25 Jul 2021 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| peer support program | Experimental | Other: peer support programA 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. |
| progressive relaxation exercise group | Experimental | Other: peer support programThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- did not have sleep apnea,
- did not musculoskeletal disease
- did not cardio-pulmonary disease
- did not psychiatric disease
- did not use drugs, cigarettes, alcohol
Key exclusion criteria (7 listed)
- Clinical diagnosis of sleep apnea
- musculoskeletal disease
- cardio-pulmonary disease
- psychiatric disease
- history of drugs, smoking, and alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peer support programAlso: progressive relaxation exercises programPeer 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) | Other | peer support program, progressive relaxation exercise group |
Primary outcome
State and Trait Anxiety Inventory
Time frame: 16 weeks
questionnaire
1 secondary outcome
Pittsburgh Sleep Quality Index
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
Healthy Aging
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma TOPKARA, Dr. study chair
Eskişehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peer support program in people with Anxiety and Sleep Disturbance, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State and Trait Anxiety Inventory (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.