AnxietyNCT07877012
4-7-8 Breathing Before Colonoscopy: Effects on Anxiety, Pain, and Embarrassment
A study testing 4-7-8 Breathing Technique in people with Anxiety and Pain, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of the 4-7-8 breathing technique performed before colonoscopy on patients' anxiety, pain, and embarrassment. Colonoscopy is a procedure used to examine the inside of the large intestine and may cause anxiety, discomfort, and embarrassment in some patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- 4-7-8 Breathing Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2024to 1 Jun 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were eligible for inclusion if they were aged 18 years or older, had effective verbal communication skills, were scheduled for their first-ever colonoscopy, were fully conscious and oriented, experienced no intraoperative or postoperative complications, had no diagnosed neurological or psychiatric disorders, and agreed to participate voluntarily
Who cannot join
- Patients were excluded if they were under 18 years of age, had hearing or speech impairments that would prevent understanding of the breathing technique instructions, regularly used anxiolytics or sedatives, or exhibited abnormal vital sign fluctuations requiring acute medical intervention during or after the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the 4-7-8 Breathing Technique Applied Before Colonoscopy on Anxiety, Pain, and Embarrassment
This study aimed to evaluate the effects of the 4-7-8 breathing technique performed before colonoscopy on patients' anxiety, pain, and embarrassment. Colonoscopy is a procedure used to examine the inside of the large intestine and may cause anxiety, discomfort, and embarrassment in some patients.
In this randomized controlled study, 104 patients undergoing colonoscopy were assigned to either an intervention group or a control group. Patients in the intervention group performed the 4-7-8 breathing technique before colonoscopy, while patients in the control group received usual care. Anxiety, pain, and embarrassment were assessed to compare outcomes between the two groups.
This study aimed to evaluate the effects of the 4-7-8 breathing technique performed before colonoscopy on patients' anxiety levels, pain intensity, feelings of embarrassment, and physiological parameters.
- Being tested
- 4-7-8 Breathing Technique
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-7-8 Breathing TechniqueBehavioural
Participants received individualized instruction on the 4-7-8 breathing technique from the principal investigator approximately 30 minutes before colonoscopy. The technique involved inhaling through the nose for 4 seconds, holding the breath for 7 seconds, and exhaling slowly through the mouth for 8 seconds. Participants completed four breathing cycles per set and two sets in total, with an intervention duration of approximately 8-10 minutes. After the exercise, participants rested for 10 minutes in a quiet pre-procedural room before the pre-procedural assessments and sedatio
| Study group | Role | What they receive |
|---|---|---|
| 4-7-8 Breathing Exercise Group | Experimental | Not described Receives: Behavioral: 4-7-8 Breathing Technique |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Level (State Anxiety Inventory Score)
Anxiety was assessed using the State-Trait Anxiety Inventory-State subscale (STAI-S) at baseline (T0), immediately before sedation and colonoscopy (T1), and after the procedure when the patient had fully recovered (T2). Scores were compared between the intervention and control groups.
Measured: Baseline (T0), immediately before sedation and colonoscopy (T1), and after the procedure following full cognitive recovery (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start30 Nov 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877012
- Sponsor's protocol ID
- CBU478
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the 4-7-8 Breathing Technique Applied Before Colonoscopy on Anxiety, Pain, and Embarrassment
- ClinicalTrials.gov ID
- NCT07877012
- Acronym / sponsor ID
- CBU478
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 15 Oct 2026 (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.
This study aimed to evaluate the effects of the 4-7-8 breathing technique performed before colonoscopy on patients' anxiety, pain, and embarrassment. Colonoscopy is a procedure used to examine the inside of the large intestine and may cause anxiety, discomfort, and embarrassment in some patients.
In this randomized controlled study, 104 patients undergoing colonoscopy were assigned to either an intervention group or a control group. Patients in the intervention group performed the 4-7-8 breathing technique before colonoscopy, while patients in the control group received usual care. Anxiety, pain, and embarrassment were assessed to compare outcomes between the two groups.
This study aimed to evaluate the effects of the 4-7-8 breathing technique performed before colonoscopy on patients' anxiety levels, pain intensity, feelings of embarrassment, and physiological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-7-8 Breathing Exercise Group | Experimental | Behavioral: 4-7-8 Breathing Technique |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were eligible for inclusion if they were aged 18 years or older, had effective verbal communication skills, were scheduled for their first-ever colonoscopy, were fully conscious and oriented, experienced no intraoperative or postoperative complications, had no diagnosed neurological or psychiatric disorders, and agreed to participate voluntarily
Key exclusion criteria (1 listed)
- Patients were excluded if they were under 18 years of age, had hearing or speech impairments that would prevent understanding of the breathing technique instructions, regularly used anxiolytics or sedatives, or exhibited abnormal vital sign fluctuations requiring acute medical intervention during or after the procedure.
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 |
|---|---|---|
| 4-7-8 Breathing TechniqueParticipants received individualized instruction on the 4-7-8 breathing technique from the principal investigator approximately 30 minutes before colonoscopy. The technique involved inhaling through the nose for 4 seconds, holding the breath for 7 seconds, and exhaling slowly through the mouth for 8 seconds. Participants completed four breathing cycles per set and two sets in total, with an intervention duration of approximately 8-10 minutes. After the exercise, participants rested for 10 minutes in a quiet pre-procedural room before the pre-procedural assessments and sedatio | Behavioural | 4-7-8 Breathing Exercise Group |
Primary outcome
Anxiety Level (State Anxiety Inventory Score)
Time frame: Baseline (T0), immediately before sedation and colonoscopy (T1), and after the procedure following full cognitive recovery (T2).
Anxiety was assessed using the State-Trait Anxiety Inventory-State subscale (STAI-S) at baseline (T0), immediately before sedation and colonoscopy (T1), and after the procedure when the patient had fully recovered (T2). Scores were compared between the intervention and control groups.
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 15 Oct 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 4-7-8 Breathing Technique in people with Anxiety and Pain, run by Manisa Celal Bayar 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 1 inclusion and 1 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 15 Oct 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?
Anxiety Level (State Anxiety Inventory Score) (time frame: Baseline (T0), immediately before sedation and colonoscopy (T1), and after the procedure following full cognitive recovery (T2).). 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 15 Oct 2026.