Pain, AcuteNCT04356820
The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination
A study testing acupressure in people with Pain, Acute and Anxiety Acute, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was carried out to determine the effect of listening to music and acupressure application in reducing pain and anxiety during gynecological examination. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Anxiety Acute
- What is being tested?
- acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 10 Sep 2019
- 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 19 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - not to be pregnant,
- no hearing problems
- Being between the ages of 19 and 65, Not having any psychiatric illness,
- No gynecological cancer, Not to have any deformity in her extremities
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study was carried out to determine the effect of listening to music and acupressure application in reducing pain and anxiety during gynecological examination.
- Conditions
- Pain, Acute, Anxiety Acute
- Being tested
- acupressure
- Keywords
- acupressure,, nursing, music, gynecological examination
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureOther
Also called music
Data collection took about 10 to 15 minutes. Then the woman invited to the examination room was asked to pull one of the envelopes with the names of the groups. The women who pulled the acupressure envelope were given a semi-sitting position where the acupressure application can feel comfortable and the researcher can easily apply the acupressure points. Before the acupressure application, massage was applied for 30 seconds to ensure circulation. Afterwards, 90 seconds consecutive pressures were applied to the specified acupressure points in a certain order (SP 6, Li 4), taking into account the direction of the meridian. After the examination, the pain formed during the gynecological examination was evaluated by applying the Short Form-McGill Pain Questionnaire without leaving the examination room
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | Not described Receives: Other: acupressure |
| music | Experimental | Not described Receives: Other: acupressure |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire and scale
McGill pain scale was developed by Melzack in 1987 and its validity and reliability in Turkish Yakut et al. (2007). In this study, the Short Form-McGill Pain Questionnaire (KF-MAA), whose validity and reliability was used and frequently used by Biçici (2010), was applied. This questionnaire consists of a total of 15 descriptive words to determine the sensory (11 words) and affective (4 words) dimensions of pain. In this section, the severity of pain (0 = none, 1 = mild, 2 = moderate, 3 = severe) is evaluated and three pain scores (sensory, affective and total pain rate = sensory affective) are obtained. In addition, the pain felt at the time of measurement is measured with the Visuel Analog Scale (VAS) and the total pain intensity is measured with a 6-point Likert scale. On this scale, 0 = no pain, 1 = mild, 2 = disturbing, 3 = distressing, 4 = terrible, 5 = unbearable pain.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 May 2019
- Primary completion15 Jul 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Factorial
- Model description
- randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Kucukkelepce, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356820
- Sponsor's protocol ID
- Adıyaman_Universty
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 22 Apr 2020
- 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 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Played and Acupressure Application on Pain and Anxiety in Women Undergoing Gynecological Examination
- ClinicalTrials.gov ID
- NCT04356820
- Acronym / sponsor ID
- Adıyaman_Universty
- Conditions
- Pain, Acute, Anxiety Acute
- Keywords
- acupressure,, nursing, music, gynecological examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 22 Apr 2020 (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 was carried out to determine the effect of listening to music and acupressure application in reducing pain and anxiety during gynecological examination.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Other: acupressure |
| music | Experimental | Other: acupressure |
| control | No intervention | – |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - not to be pregnant,
- no hearing problems
- Being between the ages of 19 and 65, Not having any psychiatric illness,
- No gynecological cancer, Not to have any deformity in her extremities
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| acupressureAlso: musicData collection took about 10 to 15 minutes. Then the woman invited to the examination room was asked to pull one of the envelopes with the names of the groups. The women who pulled the acupressure envelope were given a semi-sitting position where the acupressure application can feel comfortable and the researcher can easily apply the acupressure points. Before the acupressure application, massage was applied for 30 seconds to ensure circulation. Afterwards, 90 seconds consecutive pressures were applied to the specified acupressure points in a certain order (SP 6, Li 4), taking into account the direction of the meridian. After the examination, the pain formed during the gynecological examination was evaluated by applying the Short Form-McGill Pain Questionnaire without leaving the examination room | Other | acupressure, music |
Primary outcome
questionnaire and scale
Time frame: 12 weeks
McGill pain scale was developed by Melzack in 1987 and its validity and reliability in Turkish Yakut et al. (2007). In this study, the Short Form-McGill Pain Questionnaire (KF-MAA), whose validity and reliability was used and frequently used by Biçici (2010), was applied. This questionnaire consists of a total of 15 descriptive words to determine the sensory (11 words) and affective (4 words) dimensions of pain. In this section, the severity of pain (0 = none, 1 = mild, 2 = moderate, 3 = severe) is evaluated and three pain scores (sensory, affective and total pain rate = sensory affective) are obtained. In addition, the pain felt at the time of measurement is measured with the Visuel Analog Scale (VAS) and the total pain intensity is measured with a 6-point Likert scale. On this scale, 0 = no pain, 1 = mild, 2 = disturbing, 3 = distressing, 4 = terrible, 5 = unbearable pain.
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 22 Apr 2020.
- 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 acupressure in people with Pain, Acute and Anxiety Acute, run by Adiyaman University Research Hospital 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 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 22 Apr 2020. 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?
questionnaire and scale (time frame: 12 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 22 Apr 2020.