ChemotherapyNCT07828028
The Effect of the 4-7-8 Breathing Technique on Anxiety, Symptom Burden, and Sleep Quality During Chemotherapy
A study testing 4-7-8 breathing technique and routine care in people with Chemotherapy, run by Malatya Turgut Ozal University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effects of the 4-7-8 breathing technique on anxiety, symptom severity, and sleep quality during treatment. A randomized controlled trial design was employed, involving 64 participants (intervention group: n=32; control group: n=32) undergoing their third treatment cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy
- What is being tested?
- 4-7-8 breathing technique and routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 25 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requirements include being 18 years of age or older;
- not being in the third stage of the disease;
- having no communication barriers, mental or physical impairments, or visual or hearing impairments;
- being able to speak Turkish and agreeing to participate.
Who cannot join
- Those who do not agree to participate in the study,
- Those under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the 4-7-8 Breathing Technique Applied During Chemotherapy on Anxiety, Symptom Burden, and Sleep Quality
This study aims to determine the effects of the 4-7-8 breathing technique on anxiety, symptom severity, and sleep quality during treatment. A randomized controlled trial design was employed, involving 64 participants (intervention group: n=32; control group: n=32) undergoing their third treatment cycle. The intervention group received the 4-7-8 breathing technique twice daily for 21 days in addition to routine care, while the control group received routine care and standard supportive care. Data will be collected at pre-test and post-test stages using the Descriptive Information Form, the State-Trait Anxiety Inventory (STAI-State), the Edmonton Symptom Assessment System (ESAS), and the Pittsburgh Sleep Quality Index (PSQI). Data analysis will be performed using the SPSS 22.0 software.
- Conditions
- Chemotherapy
- Being tested
- 4-7-8 breathing technique, routine care
- Keywords
- 4-7-8 breathing technique, chemotherapy, symptom burden, sleep quality, anxiety, cancer, oncology nursing
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Neoplasms
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 in the intervention group will receive routine chemotherapy care in addition to the 4-7-8 breathing technique. The technique will be taught individually by the researcher face-to-face before chemotherapy. Participants will perform the technique twice daily, once in the morning and once in the evening, for 21 consecutive days. Each session will consist of four cycles of the 4-7-8 breathing technique.
routine careOther
Participants in the control group will receive routine nursing care and standard chemotherapy care according to the usual clinical practice. No 4-7-8 breathing technique will be provided during the study period.
| Study group | Role | What they receive |
|---|---|---|
| 4-7-8 Breathing Technique | Experimental | Participants receiving the 3rd cycle of chemotherapy will be assigned to the intervention group. Participants will receive routine nursing care and standard chemotherapy care in addition to the 4-7-8 breathing technique. The breathing technique will be individually taught face-to-face by the researcher before chemotherapy. Participants will perform the technique twice daily, in the morning and evening, for 21 consecutive days. Each session will consist of four cycles of the 4-7-8 breathing technique. Assessments will be performed at baseline and on the 21st day to evaluate anxiety, chemotherapy symptom burden, and sleep quality. Receives: Behavioral: 4-7-8 breathing technique; Other: routine care |
| Routine Care | Active comparator | Participants receiving the 3rd cycle of chemotherapy will be assigned to the control group. Participants will receive routine nursing care and standard chemotherapy care according to usual clinical practice. The 4-7-8 breathing technique will not be provided during the 21-day study period. Assessments will be performed at baseline and on the 21st day to evaluate anxiety, chemotherapy symptom burden, and sleep quality. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Level
State anxiety level was assessed using the State-Trait Anxiety Inventory-State subscale (STAI-S). The STAI-S consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety. State anxiety was assessed at baseline and on Day 21.
Measured: Baseline and Day 21
Sleep Quality
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI evaluates subjective sleep quality and sleep disturbances, with higher total scores indicating poorer sleep quality. Sleep quality was assessed at baseline and on Day 21.
Measured: Baseline and Day 21
Chemotherapy Symptom Burden
Chemotherapy symptom burden was assessed using the Edmonton Symptom Assessment System (ESAS). The severity of symptoms was rated on a 0-10 numerical scale, with higher scores indicating greater symptom severity. Chemotherapy symptom burden was assessed at baseline and on Day 21.
Measured: Baseline and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start15 Mar 2025
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChemotherapyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malatya Turgut Ozal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, beyzanur ulupınar, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828028
- Sponsor's protocol ID
- E-30785963-020-306357
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient privacy and confidentiality concerns. The data are collected within a single institutional clinical study for academic thesis purposes and are not planned for public data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 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 During Chemotherapy on Anxiety, Symptom Burden, and Sleep Quality
- ClinicalTrials.gov ID
- NCT07828028
- Acronym / sponsor ID
- E-30785963-020-306357
- Conditions
- Chemotherapy
- Keywords
- 4-7-8 breathing technique, chemotherapy, symptom burden, sleep quality, anxiety, cancer, oncology nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Malatya Turgut Ozal UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 18 Sep 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 aims to determine the effects of the 4-7-8 breathing technique on anxiety, symptom severity, and sleep quality during treatment. A randomized controlled trial design was employed, involving 64 participants (intervention group: n=32; control group: n=32) undergoing their third treatment cycle. The intervention group received the 4-7-8 breathing technique twice daily for 21 days in addition to routine care, while the control group received routine care and standard supportive care. Data will be collected at pre-test and post-test stages using the Descriptive Information Form, the State-Trait Anxiety Inventory (STAI-State), the Edmonton Symptom Assessment System (ESAS), and the Pittsburgh Sleep Quality Index (PSQI). Data analysis will be performed using the SPSS 22.0 software.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-7-8 Breathing Technique | Experimental | Behavioral: 4-7-8 breathing technique, Other: routine careParticipants receiving the 3rd cycle of chemotherapy will be assigned to the intervention group. Participants will receive routine nursing care and standard chemotherapy care in addition to the 4-7-8 breathing technique. The breathing technique will be individually taught face-to-face by the researcher before chemotherapy. Participants will perform the technique twice daily, in the morning and evening, for 21 consecutive days. Each session will consist of four cycles of the 4-7-8 breathing technique. Assessments will be performed at baseline and on the 21st day to evaluate anxiety, chemotherapy symptom burden, and sleep quality. |
| Routine Care | Active comparator | Other: routine careParticipants receiving the 3rd cycle of chemotherapy will be assigned to the control group. Participants will receive routine nursing care and standard chemotherapy care according to usual clinical practice. The 4-7-8 breathing technique will not be provided during the 21-day study period. Assessments will be performed at baseline and on the 21st day to evaluate anxiety, chemotherapy symptom burden, and sleep quality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Requirements include being 18 years of age or older;
- not being in the third stage of the disease;
- having no communication barriers, mental or physical impairments, or visual or hearing impairments;
- being able to speak Turkish and agreeing to participate.
Key exclusion criteria (2 listed)
- Those who do not agree to participate in the study,
- Those under the age of 18
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 in the intervention group will receive routine chemotherapy care in addition to the 4-7-8 breathing technique. The technique will be taught individually by the researcher face-to-face before chemotherapy. Participants will perform the technique twice daily, once in the morning and once in the evening, for 21 consecutive days. Each session will consist of four cycles of the 4-7-8 breathing technique. | Behavioural | 4-7-8 Breathing Technique |
| routine careParticipants in the control group will receive routine nursing care and standard chemotherapy care according to the usual clinical practice. No 4-7-8 breathing technique will be provided during the study period. | Other | 4-7-8 Breathing Technique, Routine Care |
Primary outcome
State Anxiety Level
Time frame: Baseline and Day 21
State anxiety level was assessed using the State-Trait Anxiety Inventory-State subscale (STAI-S). The STAI-S consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety. State anxiety was assessed at baseline and on Day 21.
Sleep Quality
Time frame: Baseline and Day 21
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI evaluates subjective sleep quality and sleep disturbances, with higher total scores indicating poorer sleep quality. Sleep quality was assessed at baseline and on Day 21.
Chemotherapy Symptom Burden
Time frame: Baseline and Day 21
Chemotherapy symptom burden was assessed using the Edmonton Symptom Assessment System (ESAS). The severity of symptoms was rated on a 0-10 numerical scale, with higher scores indicating greater symptom severity. Chemotherapy symptom burden was assessed at baseline and on Day 21.
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 23 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to patient privacy and confidentiality concerns. The data are collected within a single institutional clinical study for academic thesis purposes and are not planned for public data sharing.
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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 and routine care in people with Chemotherapy, run by Malatya Turgut Ozal 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 4 inclusion and 2 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 23 Sep 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?
State Anxiety Level (time frame: Baseline and Day 21). The study lists 3 primary outcomes in all. 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 23 Sep 2026.