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HypertensionHT-LaughterNCT07148869

The Effect of Laughter Yoga Practice in Hypertension Patients

A study testing LAUGHTER YOGA in people with Hypertension and Laughter Yoga, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Hypertension (HT), which is defined as an arterial blood pressure higher than 140/90 mmHg, is an important health problem because it causes serious complications and is commonly seen in the community. Laughter as an expression of humour has been accepted as a good medicine for centuries. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension, Laughter Yoga
What is being tested?
LAUGHTER YOGA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Aug 2025to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Diagnosed with hypertension in the last one year
  • Those who volunteered to participate in the study
  • No problem preventing communication
  • No cognitive and mental problems
  • Not taking anxiolytics, antidepressants or sleeping pills
  • Individuals without an additional chronic disease that may affect breathing, such as heart failure or chronic obstructive pulmonary disease
  • Will be included in the research.

Who cannot join

  • The patient wishes to leave the study voluntarily
  • Less than 80% participation of the patient in the laughter yoga programme
  • Failure of the patient to participate in follow-up assessments
  • The patient receives additional treatments during the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Hasan Kalyoncu University

    Gaziantep

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Laughter Yoga Practice on Anxiety, Sleep Quality, Treatment Compliance and Satisfaction in Hypertension Patients

Hypertension (HT), which is defined as an arterial blood pressure higher than 140/90 mmHg, is an important health problem because it causes serious complications and is commonly seen in the community.

Laughter as an expression of humour has been accepted as a good medicine for centuries. It is also one of the practices used in nursing care according to the Nursing Interventions Classification (NIC). Laughter yoga developed by Dr. Madan Kataria, an Indian medical doctor, in 1995 includes deep breathing exercises, meditation, childish games and laughter without humour. In practice, individual sessions as well as group sessions can be held. It is important to form groups of at least 5 people in terms of the dynamics of the group. The first stage in laughter yoga is warm-up exercises. Hands are clapped parallel to each other, acupuncture points are stimulated by stimulating the fingertips and palms as clapping is performed, and a vocal rhythm in the form of ho, ho, ha-ha-ha is added to the last clapping movement. In the second stage, breathing exercises, the participants raise their arms to the sky as if praying, inhale and hold their breath for 4-5 seconds after deep inspiration and exhale rhythmically and slowly. The third stage includes childish games. The last stage is the stage of laughter exercises in which unreasonable laughter is thrown by imagining situations as if they did not exist. These exercises include milkshake laughter exercises, lion laughter, hot soup laughter, hugging laughter, bird laughter, etc. It is recommended that each session should be at least 20 minutes and should be applied for at least 8 weeks. At the end of the session, individuals are provided to relax by meditation.

Read more

The aim of this thesis study;

  • Developing the Laughter Yoga Satisfaction Scale and
  • To investigate the effect of laughter yoga practice on anxiety, sleep quality, treatment compliance and satisfaction in hypertension patients.

Hypotheses of the study H1-1: Laughter Yoga Satisfaction Scale is a valid scale. H2-1: Laughter Yoga Satisfaction Scale is a reliable scale. H3-1: Laughter yoga reduces the anxiety level of hypertension patients. H4-1: Laughter yoga improves the sleep quality of hypertension patients. H5-1: Laughter yoga increases the level of compliance with treatment in hypertension patients.

H6-1: Hypertension patients have a high level of satisfaction with laughter yoga.

H7-1: Laughter yoga has positive effects on vital signs of hypertension patients.

Read the detailed description

Patient Information Form: In the form developed by the researcher as a result of literature review, some sociodemographic characteristics of the patients (age, gender, educational status, marital status, social security, employment and income status, smoking and alcohol use) were included. and medical characteristics (duration of HT diagnosis, medications used, presence of hypertension in the family, other chronic diseases) will be included.

Life Findings Record Form: The researcher will measure the patient's blood pressure, oxygen saturation, pulse and respiratory rate, body temperature 10 minutes before and 10 minutes after the laughter yoga session and record them on this form.

Pittsburgh Sleep Quality Index (PSQI): The scale consists of 18 items and 7 components. The total PDQI score is the sum of the scores of these components and the total score takes a value between 0-21. A PDQI total score >5 indicates 'poor sleep quality' and a PDQI total score <5 indicates 'good sleep quality'. The Cronbach alpha reliability coefficient of the Turkish version of the scale was found to be 0.80.

State and Trait Anxiety Inventory (STAI): The scale consists of two separate forms, a 20-item State Anxiety Scale and a 20-item Trait Anxiety Scale. The total score value obtained from the scales is between 20 and 80 points. Scores close to 80 points indicate a high level of anxiety. Scale reliability according to Kuder-Richardson reliability: 0.83 to 0.87 for Trait Anxiety Scale and 0.94 to 0.96 for State Anxiety Scale. Item reliability correlations were found between 0.34 and 0.72 for the Trait Anxiety Scale and between 0.42 and 0.85 for the State Anxiety Scale. In the scale, which measures momentary (temporary) anxiety at a reliable level, participants tick the most appropriate option from the options of "not at all", "a little", "a lot" or "completely" for each statement in the state anxiety scores. Positive scores (increasing the total anxiety score) are given for items; negative scores (decreasing the total anxiety score) are given for items. During the evaluation, a score between 1 (or -1) and 4 (or -4) is given for each item according to the positive or negative feature of the item and a constant of 50 is added to the total score to be obtained. The highest score is 80 and the lowest score is 20. The higher the total anxiety score, the higher the anxiety level of the respondent.

Hill-Bone Hypertension Treatment Compliance Scale: The four-point Likert-type scale (0=never, 1=sometimes, 2=most of the time and 3=always) consists of 14 items and has three sub-dimensions including interview, medical and nutrition. The scores that can be obtained from the scale vary between 0 (perfect agreement) and 42 (incompatible). As the score obtained from the scale increases, treatment compliance decreases. While the Cronbach alpha value of the original scale was found to be 0.84, the Cronbach alpha reliability coefficient of the Turkish version was found to be 0.83.

Laughter Yoga Satisfaction Scale: In the first stage of the research, the scale developed by the researcher and the validity-reliability study will be used.

Being tested
LAUGHTER YOGA, control group
Keywords
Hypertension, Sleep Quality, laughter yoga, anxiety, treatment compliance
Medical subject headings
Hypertension, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LAUGHTER YOGABehavioural

    Patients will be divided into groups of at least 5 people according to the sample size. Laughter yoga sessions will be conducted under the leadership of the researcher in a suitable room / hall determined within the hospital. A total of 8 sessions will be applied, 2 sessions per week for 4 weeks, with each session lasting an average of 40 minutes.

  • control groupOther

    there will be no application to this group

Study groups in NCT07148869
Study groupRoleWhat they receive
laughter yoga groupExperimentalPatients will be divided into groups of at least 5 people according to the sample size. Laughter yoga sessions will be conducted under the leadership of the researcher in a suitable room / hall determined within the hospital. A total of 8 sessions will be applied, 2 sessions per week for 4 weeks, with each session lasting an average of 40 minutes.
Receives: Behavioral: LAUGHTER YOGA
CONTROL GROUPPlacebo comparatorthere will be no application to this group
Receives: Other: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Life Findings Record Form

    The researcher will measure the patient's blood pressure, oxygen saturation, pulse and respiratory rate, body temperature 10 minutes before and 10 minutes after the laughter yoga session and record them on this form.

    Measured: Day 1

  2. Sleep Quality

    Pittsburgh Sleep Quality Index (PSQI): The Turkish validity and reliability of the scale developed by Buysse et al. to evaluate sleep quality in the last month was performed by Ağargün et al. The scale consists of 18 items and 7 components. The total PDQI score is the sum of the scores of these components and the total score takes a value between 0-21. A PDQI total score >5 indicates 'poor sleep quality' and a PDQI total score <5 indicates 'good sleep quality'. The Cronbach alpha reliability coefficient of the Turkish version of the scale was found to be 0.80.

    Measured: Day 1

  3. State and Trait Anxiety Inventory

    State and Trait Anxiety Inventory (STAI): The scale developed by Spielberger et al. (1970) was adapted to Turkish culture and validity and reliability studies were conducted by Öner and Le Compte (1983). The scale consists of two separate forms, a 20-item State Anxiety Scale and a 20-item Trait Anxiety Scale. The total score value obtained from the scales is between 20 and 80 points. Scores close to 80 points indicate a high level of anxiety. Scale reliability according to Kuder-Richardson reliability: 0.83 to 0.87 for Trait Anxiety Scale and 0.94 to 0.96 for State Anxiety Scale. Item reliability correlations were found between 0.34 and 0.72 for the Trait Anxiety Scale and between 0.42 and 0.85 for the State Anxiety Scale. In the scale, which measures momentary (temporary) anxiety at a reliable level, participants tick the most appropriate option from the options of "not at all", "a little", "a lot" or "completely" for each statement in the state anxiety scores. Positive scores (incre

    Measured: Day 1

  4. Hill-Bone Hypertension Treatment Compliance

    Hill-Bone Hypertension Treatment Compliance Scale: The Turkish validity and reliability of the scale developed by Kim et al. was performed by Karademir et al. The four-point Likert-type scale (0=never, 1=sometimes, 2=most of the time and 3=always) consists of 14 items and has three sub-dimensions including interview, medical and nutrition. The scores that can be obtained from the scale vary between 0 (perfect agreement) and 42 (incompatible). As the score obtained from the scale increases, treatment compliance decreases. While the Cronbach alpha value of the original scale was found to be 0.84, the Cronbach alpha reliability coefficient of the Turkish version was found to be 0.83.

    Measured: Day 1

  5. Laughter Yoga Satisfaction

    Laughter Yoga Satisfaction Scale: In the first phase of the study, the scale developed by the researcher and the validity-reliability study will be used. On a scale ranging from a minimum of 13 to a maximum of 65, it is shown that satisfaction increases as the score increases.

    Measured: Day 4

Secondary outcomes (5)
  1. Sleep Quality

    Pittsburgh Sleep Quality Index (PSQI): The Turkish validity and reliability of the scale developed by Buysse et al. to evaluate sleep quality in the last month was performed by Ağargün et al. The scale consists of 18 items and 7 components. The total PDQI score is the sum of the scores of these components and the total score takes a value between 0-21. A PDQI total score >5 indicates 'poor sleep quality' and a PDQI total score <5 indicates 'good sleep quality'. The Cronbach alpha reliability coefficient of the Turkish version of the scale was found to be 0.80.

    Measured: four weeks later

  2. State and Trait Anxiety Inventory

    State and Trait Anxiety Inventory (STAI): The scale developed by Spielberger et al. (1970) was adapted to Turkish culture and validity and reliability studies were conducted by Öner and Le Compte (1983). The scale consists of two separate forms, a 20-item State Anxiety Scale and a 20-item Trait Anxiety Scale. The total score value obtained from the scales is between 20 and 80 points. Scores close to 80 points indicate a high level of anxiety. Scale reliability according to Kuder-Richardson reliability: 0.83 to 0.87 for Trait Anxiety Scale and 0.94 to 0.96 for State Anxiety Scale. Item reliability correlations were found between 0.34 and 0.72 for the Trait Anxiety Scale and between 0.42 and 0.85 for the State Anxiety Scale. In the scale, which measures momentary (temporary) anxiety at a reliable level, participants tick the most appropriate option from the options of "not at all", "a little", "a lot" or "completely" for each statement in the state anxiety scores. Positive scores (incre

    Measured: four weeks later

  3. Hill-Bone Hypertension Treatment Compliance

    Hill-Bone Hypertension Treatment Compliance Scale: The Turkish validity and reliability of the scale developed by Kim et al. was performed by Karademir et al. The four-point Likert-type scale (0=never, 1=sometimes, 2=most of the time and 3=always) consists of 14 items and has three sub-dimensions including interview, medical and nutrition. The scores that can be obtained from the scale vary between 0 (perfect agreement) and 42 (incompatible). As the score obtained from the scale increases, treatment compliance decreases. While the Cronbach alpha value of the original scale was found to be 0.84, the Cronbach alpha reliability coefficient of the Turkish version was found to be 0.83.

    Measured: four weeks later

  4. Laughter Yoga Satisfaction

    Laughter Yoga Satisfaction Scale: In the first stage of the research, the scale developed by the researcher and the validity-reliability study will be used.

    Measured: four weeks later

  5. Life Findings Record Form

    The researcher will measure the patient's blood pressure, oxygen saturation, pulse and respiratory rate, body temperature 10 minutes before and 10 minutes after the laughter yoga session and record them on this form.

    Measured: up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2025
  2. Study start20 Aug 2025 (estimated)
  3. Primary completion20 Sep 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Model description
Parallel Assignment
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07148869
Sponsor's protocol ID
HASAN KALYONCU UNIVERSITY
Acronym
HT-Laughter
Status last verified
Aug 2025
First submitted
18 Jul 2025
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: the study can be shared after publication

Questions about this trial

What is this clinical trial studying?

A study testing LAUGHTER YOGA in people with Hypertension and Laughter Yoga, run by Kilis 7 Aralik 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 4 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: opening soon, as of the sponsor's last update on 29 Aug 2025. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GULSEN KARATAS (+905054846160, glsnkrts002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Life Findings Record Form (time frame: Day 1). The study lists 5 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 29 Aug 2025.

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