Stress-related ProblemNCT03593551
Effects of Different Relaxation Interventions on Reducing Stress in Chinese Breastfeeding Mothers
A study of Stress-related Problem and Breastfeeding, run by University College, London at 1 site in China.
Trial summary
This pilot study aims to find the most effective relaxation technique to help primiparous mothers who are breastfeeding their infant. The effect of five different relaxation techniques on physical and psychological changes in Chinese mothers will be investigated. Read more about this study
- Who is it for?
- Ages 23 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress-related Problem, Breastfeeding, Relaxation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2018to 28 Jun 2018
- 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 23 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- primiparous mothers who are currently breastfeeding their infants
- generally healthy (without any diseases that could influence their blood pressure, heart rate, energy expenditure, or breastfeeding practice)
- did not attend any other intervention studies within 12 months
Who cannot join
- Smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Different Relaxation Interventions on Physical and Psychological Changes in Breastfeeding Mothers in China: A Pilot Study
This pilot study aims to find the most effective relaxation technique to help primiparous mothers who are breastfeeding their infant. The effect of five different relaxation techniques on physical and psychological changes in Chinese mothers will be investigated. The interventions to be used in this study include: guided relaxation meditation tape, music tape, relaxation lighting, combined relaxation meditation and lighting, and combined music and lighting.
Read the detailed description
The study will be conducted at Beijing Children Hospital, Beijing, China. A within-subject design will be used to evaluate the effectiveness and participants' feeling towards the five tested interventions compared to a control situation.
Population and recruitment The study population will be breastfeeding women in China. Recruitment will be take place through social media and community flyers in Beijing Children Hospital. Advertisements will be posted in the hospital while flyers will be sent to local communities. Interested women can make contact by email. Details about the study will be explained in the information sheet. After checking the eligibility and obtaining written informed consent, all eligible participants will be enrolled in the study.
Sample size calculation
To estimate the sample size of this pilot study, standard formulas used for calculation are:
Sample size (per equal-sized group) =8 x standard deviation ÷ (difference) 2
Here the effect size and standard deviation (SD) are estimated from a previous research, which evaluated the effect of audio-visual imagery on patient anxiety and physiological parameters. A sample of 51 patients was able to demonstrate a significant reduction in HR (mean change (Z)= -0.75, SD= 1.00; p=0.01). Accordingly, the estimated sample size (per equal-sized group) would be 28. However, since the present study will use a within-subject design, a sample of 14 participants will likely be able to demonstrate changes. Considering the potential drop-out rates, a total of 15-20 subjects will be enrolled in this study.
Study Procedures After obtaining informed consent, all participants enrolled in this study will be asked to attend for 30 minutes once to three times per week for five relaxation treatments and one control treatment (no intervention). The emotions and feelings of participants in both intervention and control treatment will be assessed before and after each treatment or control.
The duration of this study is six weeks. In order to fit with the subject's schedule and control the circadian rhythm, all treatments and control sessions will take place on different days each week. Each participant can choose a 30-minute time slot to fit participants' timetable. To make the outcome assessment more consistent, participants are encouraged to come at the same time of the day they chose. The order of interventions will be randomly assigned for each participant. Both relaxation interventions and control will be conducted in the breastfeeding room located at Beijing Children Hospital. This room is private, quiet and has comfy seating. Participants will be asked to leave their personal belongings, including any electronic devices, books and magazines, and personal work, during the experiment period.
Outcome measurements Primary outcomes of this study will be perceived relaxation level. Secondary outcomes are heart rate (HR), blood pressure (BP) and fingertip temperature (FT).
The HR, BP and FT will be measured at both the start and the end of the experiment. An automatic BP machine will be used for the measurements of HR and BP. The BP will be measured three times and the mean of three will be calculated and recorded. A thermometer will be used for the FT measurement.
The perceived relaxation will be assessed by a visual analogue scale (VAS), which consists of a horizontal 10cm line with one end representing the maximum and the other end the minimum of the variable to be measured. The right anchor of the scale is labelled as "completely relaxed" and the left anchor as "completely unrelaxed". Participants indicate their state of relaxation by marking a point along the line before each session and again at the end of each session. The distance from the left anchor to the mark made by participants is measured in millimeters and pre and post-test differences are compared.
Statistical analysis Data will be analysed using SPSS 24.0. Paired t-test will be used to detect changes in each of the primary outcomes before and after the treatment. One-way ANOVA will be conducted to find differences between control and each intervention group. Post-hoc analysis will be used to compare the effectiveness of each treatment. Differences will be considered statistically significant at p<0.05.
- Being tested
- five relaxation treatments and one control
- Keywords
- stress, anxiety, breastfeeding, relaxation, meditation, music
- Medical subject headings
- Breast Feeding, Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
five relaxation treatments and one controlCombination product
Five treatments are relaxation meditation tape, music tape, relaxation lighting, meditation tape plus lighting, and music plus lighting. The control session have no intervention, participants will just be asked to sit comfortably for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| relaxation and control | Experimental | All participants will attend five relaxation treatments and one control. The order of treatments and control will be randomised allocated to participants. Receives: Combination Product: five relaxation treatments and one control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived relaxation
Perceived relaxation measured by a visual analogue scale which consists of a horizontal 10cm line.The right anchor of the scale is identified as "completely relaxed" and the left anchor as"completely unrelaxed".
Measured: 3 minutes
Secondary outcomes (3)
Fingertip temperature
Fingertip temperature measured by Digital Body Thermometer in degrees centigrade. (A higher temperature is an indication of greater relaxation).
Measured: 10 seconds
Heart rate
Heart rate measured by electronic blood pressure machine. A lower heart rate indicates greater relaxation.
Measured: 2 minutes
Blood pressure
Systolic and diastolic pressure measured by electronic blood pressure machine. A lower BP indicates greater relaxation.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start3 Jun 2018
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress-related ProblemStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Treatment
- Intervention model
- Sequential
- Model description
- within study design
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Fewtrell, University College, London
- Investigators
- Mary Fewtrell, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593551
- Sponsor's protocol ID
- 12681/001
- Status last verified
- Jul 2018
- First submitted
- 10 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Different Relaxation Interventions on Physical and Psychological Changes in Breastfeeding Mothers in China: A Pilot Study
- ClinicalTrials.gov ID
- NCT03593551
- Acronym / sponsor ID
- 12681/001
- Keywords
- stress, anxiety, breastfeeding, relaxation, meditation, music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 3 Jun 2018 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 20 Jul 2018 (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 pilot study aims to find the most effective relaxation technique to help primiparous mothers who are breastfeeding their infant. The effect of five different relaxation techniques on physical and psychological changes in Chinese mothers will be investigated. The interventions to be used in this study include: guided relaxation meditation tape, music tape, relaxation lighting, combined relaxation meditation and lighting, and combined music and lighting.
Detailed description
The study will be conducted at Beijing Children Hospital, Beijing, China. A within-subject design will be used to evaluate the effectiveness and participants' feeling towards the five tested interventions compared to a control situation.
Population and recruitment The study population will be breastfeeding women in China. Recruitment will be take place through social media and community flyers in Beijing Children Hospital. Advertisements will be posted in the hospital while flyers will be sent to local communities. Interested women can make contact by email. Details about the study will be explained in the information sheet. After checking the eligibility and obtaining written informed consent, all eligible participants will be enrolled in the study.
Sample size calculation
To estimate the sample size of this pilot study, standard formulas used for calculation are:
Sample size (per equal-sized group) =8 x standard deviation ÷ (difference) 2
Here the effect size and standard deviation (SD) are estimated from a previous research, which evaluated the effect of audio-visual imagery on patient anxiety and physiological parameters. A sample of 51 patients was able to demonstrate a significant reduction in HR (mean change (Z)= -0.75, SD= 1.00; p=0.01). Accordingly, the estimated sample size (per equal-sized group) would be 28. However, since the present study will use a within-subject design, a sample of 14 participants will likely be able to demonstrate changes. Considering the potential drop-out rates, a total of 15-20 subjects will be enrolled in this study.
Study Procedures After obtaining informed consent, all participants enrolled in this study will be asked to attend for 30 minutes once to three times per week for five relaxation treatments and one control treatment (no intervention). The emotions and feelings of participants in both intervention and control treatment will be assessed before and after each treatment or control.
The duration of this study is six weeks. In order to fit with the subject's schedule and control the circadian rhythm, all treatments and control sessions will take place on different days each week. Each participant can choose a 30-minute time slot to fit participants' timetable. To make the outcome assessment more consistent, participants are encouraged to come at the same time of the day they chose. The order of interventions will be randomly assigned for each participant. Both relaxation interventions and control will be conducted in the breastfeeding room located at Beijing Children Hospital. This room is private, quiet and has comfy seating. Participants will be asked to leave their personal belongings, including any electronic devices, books and magazines, and personal work, during the experiment period.
Outcome measurements Primary outcomes of this study will be perceived relaxation level. Secondary outcomes are heart rate (HR), blood pressure (BP) and fingertip temperature (FT).
The HR, BP and FT will be measured at both the start and the end of the experiment. An automatic BP machine will be used for the measurements of HR and BP. The BP will be measured three times and the mean of three will be calculated and recorded. A thermometer will be used for the FT measurement.
The perceived relaxation will be assessed by a visual analogue scale (VAS), which consists of a horizontal 10cm line with one end representing the maximum and the other end the minimum of the variable to be measured. The right anchor of the scale is labelled as "completely relaxed" and the left anchor as "completely unrelaxed". Participants indicate their state of relaxation by marking a point along the line before each session and again at the end of each session. The distance from the left anchor to the mark made by participants is measured in millimeters and pre and post-test differences are compared.
Statistical analysis Data will be analysed using SPSS 24.0. Paired t-test will be used to detect changes in each of the primary outcomes before and after the treatment. One-way ANOVA will be conducted to find differences between control and each intervention group. Post-hoc analysis will be used to compare the effectiveness of each treatment. Differences will be considered statistically significant at p<0.05.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- within study design
| Arm | Type | Receives |
|---|---|---|
| relaxation and control | Experimental | Combination Product: five relaxation treatments and one controlAll participants will attend five relaxation treatments and one control. The order of treatments and control will be randomised allocated to participants. |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- primiparous mothers who are currently breastfeeding their infants
- generally healthy (without any diseases that could influence their blood pressure, heart rate, energy expenditure, or breastfeeding practice)
- did not attend any other intervention studies within 12 months
Key exclusion criteria (1 listed)
- Smoker
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 |
|---|---|---|
| five relaxation treatments and one controlFive treatments are relaxation meditation tape, music tape, relaxation lighting, meditation tape plus lighting, and music plus lighting. The control session have no intervention, participants will just be asked to sit comfortably for 10 minutes. | Combination product | relaxation and control |
Primary outcome
Perceived relaxation
Time frame: 3 minutes
Perceived relaxation measured by a visual analogue scale which consists of a horizontal 10cm line.The right anchor of the scale is identified as "completely relaxed" and the left anchor as"completely unrelaxed".
3 secondary outcomes
Fingertip temperature
Time frame: 10 seconds
Heart rate
Time frame: 2 minutes
Blood pressure
Time frame: 2 minutes
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 26 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mary Fewtrell, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stress-related Problem and Breastfeeding, run by University College, London at 1 site in China.
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 3 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 26 Jul 2018. 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 China. 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?
Perceived relaxation (time frame: 3 minutes). 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 26 Jul 2018.