AnxietyNCT06870214
Benson Relaxation Technique and Stress in Pregnancy
A study testing relaxation in people with Anxiety and Stress, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of the Benson Relaxation Technique applied to pregnant women on their fear of birth, anxiety and stress levels. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Stress, Relation, Interpersonal
- What is being tested?
- relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 30 Jun 2026
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who are in their 28th-38th weeks of pregnancy,
- People with mental illness,
- People who have Anxiety disorder,
- People with hearing loss;
- People who have no experience of using relaxation methods in the past,
- People who have not used herbal or medical sedatives
Who cannot join
- Those who do not want to participate in the intervention,
- Those who have a termination of pregnancy during the intervention,
- Those who have a risky pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ''Investigation of the Effect of Benson Relaxation Technique Applied to Pregnant Women on Fear of Childbirth, Anxiety and Stress Levels of Pregnant Women''
The aim of this study is to determine the effect of the Benson Relaxation Technique applied to pregnant women on their fear of birth, anxiety and stress levels.
Read the detailed description
The aim of this study is to determine the effect of the Benson Relaxation Technique applied to pregnant women on their fear of birth, anxiety and stress levels.
Hypotheses ; H0-1: Benson relaxation technique applied to pregnant women has an effect on childbirth.
H1-1: Benson relaxation technique applied to pregnant women has no effect on childbirth.
H0-2: Benson relaxation technique applied to pregnant women has no effect on anxiety.
H1-2: Benson relaxation technique applied to pregnant women has an effect on anxiety.
H0-3: Benson relaxation technique applied to pregnant women and their partners has no effect on stress.
H1-3: Benson relaxation technique applied to pregnant women and their partners has an effect on stress The study will be conducted on two different groups. The application will be a 1-hour Benson relaxation technique applied to pregnant women in the third trimester every week for 4 weeks. Participants will be asked to do relaxation exercises twice a day, morning and evening, for 10 to 15 minutes for 1 month. A phone number that patients can call with questions will also be provided. In addition, the researcher will call the women in the intervention group every week to follow up on the relaxation process and answer questions.
After the women are evaluated in terms of eligibility criteria for the study, information about the study will be provided to the women who are eligible and written informed consent will be obtained from the women who accept. The random distribution of the women to the study groups will be carried out using the Block Randomization method. The following applications will be applied to the groups.
The researcher will contact the experimental group by phone. The application will end after 4 weeks.
- Conditions
- Anxiety, Stress, Relation, Interpersonal
- Being tested
- relaxation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxationOther
Also called control group
Women in the 3rd trimester will receive routine care only.
| Study group | Role | What they receive |
|---|---|---|
| relaxation group | Experimental | They will be interviewed according to the inclusion criteria and exclusion criteria, and they will be informed about the study and their consent will be obtained, the participant information form and depression form will be filled, a pre-test will be performed and the communication will be completed. Their numbers will be taken.
The intervention group will be given a 1-hour Benson relaxation technique every week for 4 weeks. Participants will be asked to do relaxation exercises for 10 to 15 minutes twice a day, in the morning and evening, for 1 month. A phone number will be provided for patients to call if they have questions. In addition, the researcher will call the women in the intervention group every week to follow up on the relaxation process and answer questions.
The researcher will contact the experimental group by phone. He/she will introduce himself/herself and final tests will be conducted after 4 weeks. Receives: Other: relaxation |
| control group | No intervention | "Routine nursing care will be provided." |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Change in anxiety
Beck Anxiety Inventory scale (BAI). The BAI measures only the frequency of anxiety symptoms in detail. It is a Likert-type self-assessment scale comprised of 21 items scored between 0 and 3. The higher the total score, the higher the anxiety experienced by the person (minimal: 0-7, mild: 8-15, moderate:16-25, and severe: 26-63 points). 18 The Turkish validity and reliability of the BSI has been reported by Ulusoy et al.
Measured: immediately intervention 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start15 Jun 2025
- Primary completion15 Jun 2026
- Study completion30 Jun 2026
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 Ondokuz Mayıs 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye BAL, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870214
- Sponsor's protocol ID
- 2024-930
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2025
- Last updated
- 9 Jul 2026
- Results posted
- 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ''Investigation of the Effect of Benson Relaxation Technique Applied to Pregnant Women on Fear of Childbirth, Anxiety and Stress Levels of Pregnant Women''
- ClinicalTrials.gov ID
- NCT06870214
- Acronym / sponsor ID
- 2024-930
- Conditions
- Anxiety, Stress, Relation, Interpersonal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 11 Mar 2025 (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 aim of this study is to determine the effect of the Benson Relaxation Technique applied to pregnant women on their fear of birth, anxiety and stress levels.
Detailed description
The aim of this study is to determine the effect of the Benson Relaxation Technique applied to pregnant women on their fear of birth, anxiety and stress levels.
Hypotheses ; H0-1: Benson relaxation technique applied to pregnant women has an effect on childbirth.
H1-1: Benson relaxation technique applied to pregnant women has no effect on childbirth.
H0-2: Benson relaxation technique applied to pregnant women has no effect on anxiety.
H1-2: Benson relaxation technique applied to pregnant women has an effect on anxiety.
H0-3: Benson relaxation technique applied to pregnant women and their partners has no effect on stress.
H1-3: Benson relaxation technique applied to pregnant women and their partners has an effect on stress The study will be conducted on two different groups. The application will be a 1-hour Benson relaxation technique applied to pregnant women in the third trimester every week for 4 weeks. Participants will be asked to do relaxation exercises twice a day, morning and evening, for 10 to 15 minutes for 1 month. A phone number that patients can call with questions will also be provided. In addition, the researcher will call the women in the intervention group every week to follow up on the relaxation process and answer questions.
After the women are evaluated in terms of eligibility criteria for the study, information about the study will be provided to the women who are eligible and written informed consent will be obtained from the women who accept. The random distribution of the women to the study groups will be carried out using the Block Randomization method. The following applications will be applied to the groups.
The researcher will contact the experimental group by phone. The application will end after 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| relaxation group | Experimental | Other: relaxationThey will be interviewed according to the inclusion criteria and exclusion criteria, and they will be informed about the study and their consent will be obtained, the participant information form and depression form will be filled, a pre-test will be performed and the communication will be completed. Their numbers will be taken. The intervention group will be given a 1-hour Benson relaxation technique every week for 4 weeks. Participants will be asked to do relaxation exercises for 10 to 15 minutes twice a day, in the morning and evening, for 1 month. A phone number will be provided for patients to call if they have questions. In addition, the researcher will call the women in the intervention group every week to follow up on the relaxation process and answer questions. The researcher will contact the experimental group by phone. He/she will introduce himself/herself and final tests will be conducted after 4 weeks. |
| control group | No intervention | –"Routine nursing care will be provided." |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Those who are in their 28th-38th weeks of pregnancy,
- People with mental illness,
- People who have Anxiety disorder,
- People with hearing loss;
- People who have no experience of using relaxation methods in the past,
Key exclusion criteria (3 listed)
- Those who do not want to participate in the intervention,
- Those who have a termination of pregnancy during the intervention,
- Those who have a risky pregnancy
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 |
|---|---|---|
| relaxationAlso: control groupWomen in the 3rd trimester will receive routine care only. | Other | relaxation group |
Primary outcome
1.Change in anxiety
Time frame: immediately intervention 4 weeks later
Beck Anxiety Inventory scale (BAI). The BAI measures only the frequency of anxiety symptoms in detail. It is a Likert-type self-assessment scale comprised of 21 items scored between 0 and 3. The higher the total score, the higher the anxiety experienced by the person (minimal: 0-7, mild: 8-15, moderate:16-25, and severe: 26-63 points). 18 The Turkish validity and reliability of the BSI has been reported by Ulusoy et al.
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 9 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relaxation in people with Anxiety and Stress, run by Ondokuz Mayıs 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 6 inclusion and 3 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 9 Jul 2026. 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?
1.Change in anxiety (time frame: immediately intervention 4 weeks later). 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 9 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.